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Contrast Media & Molecular Imaging 2022The efficacy and adverse reactions of remimazolam besylate (RB) in combination with alfentanil in patients with painless gastroscopy remain unclear. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The efficacy and adverse reactions of remimazolam besylate (RB) in combination with alfentanil in patients with painless gastroscopy remain unclear.
OBJECTIVE
The aim of the study is to observe the efficacy and adverse reactions of RB in combination with alfentanil in patients with painless gastroscopy RB.
METHODS
All patients were randomly divided into two groups: RB combined with the alfentanil group (research group) and propofol combined with the alfentanil group (control group). After full oxygen inhalation and electrocardiographic monitoring, the research group was given 10 g/Kg alfentanil + RB 0.2 mg/kg intravenously, and the control group was given 10 g/Kg alfentanil + propofol 1.5 mg/kg. If there is a clinical need, the research group was given 2.5 mg/additional RB, whereas the control group was treated with an additional 0.5 mg/kg propofol. Main outcome measures were as follows: The vital endpoints including diachronic changes in heart rate (HR), blood pressure (BP), respiratory rate (RR), blood oxygen saturation (SPO), end-expiratory carbon dioxide (etCO), IPI, modified observer's assessment of alert/sedation (MOAA/S), time-related endpoints, perioperative adverse events, endoscopy, and anesthesiologist satisfaction, and 24-hour follow-up of adverse reactions, IPI scores, and satisfaction were recorded.
RESULTS
The HR and BP of the patients in the research group and the control group decreased, with a greater decrease in the control group, and the difference was statistically significant ( < 0.05). The values of RR, PETCO, and IPI in the research group and the control group decreased to the lowest at 2-3 min but the decrease in the control group was more significant. Furthermore, there was no significant difference in the time from the completion of administration to 4 minutes of IPI and the total examination time, but the awakening time in the research group was slightly longer than that in the control group, and the difference was statistically significant ( < 0.05). The incidences of respiratory depression and hypotension during the operation were shown to be markedly smaller in the investigation relative to the control team, and the difference was statistically significant ( < 0.05), whereas the occurrence of cough, movements, and singultus was more common in the investigations, and the difference was statistically significant ( < 0.05). The results of the 24-hour follow-up showed that the adverse reactions such as nausea, dizziness, fatigue, abdominal pain, and abdominal distension were much less frequent in the study team, and the difference was statistically significant ( < 0.05), and the patient satisfaction was higher than in the control group, and the difference was statistically significant ( < 0.05). The regression results showed that age, sedative, and total dose of analgesia had significant effects on the results, and the covariance coefficient of sedative was 1.57 of IPI score in the research group higher than that of the control group.
CONCLUSIONS
RB combined with alfentanil can provide safe and effective sedation for patients undergoing painless gastroscopy. Compared with propofol, RB and alfentanil for injection can avoid large hemodynamic fluctuations and deep sedation, and have fewer adverse reactions. However, the cases involved in this study are all from a single-center data, which requires further multicenter research and conformation.
Topics: Humans; Alfentanil; Propofol; Single-Blind Method; Gastroscopy; Carbon Dioxide; Conscious Sedation; Hypnotics and Sedatives; Oxygen
PubMed: 36263002
DOI: 10.1155/2022/7102293 -
BMC Anesthesiology Feb 2022We aimed to determine the time interval between alfentanil and rocuronium administration, at a 50% probability of preventing pain-induced withdrawal movement from...
BACKGROUND
We aimed to determine the time interval between alfentanil and rocuronium administration, at a 50% probability of preventing pain-induced withdrawal movement from rocuronium injection (Time50).
METHODS
A total of 64 patients scheduled for general anesthesia were enrolled in this study (33 men and 31 women). Anesthesia was induced with target-controlled infusion of propofol, at an effect-site target concentration of 3 μg/mL. Then, alfentanil 15 μg/kg was injected for 30 s. After 60 s, rocuronium 0.6 mg/kg was administered to the first patient. The Dixon's up-and-down method was used to determine the time interval for each subsequent patient (interval of 5 s). Mean arterial pressure (MAP) and heart rate (HR) were recorded at three time points: T0, pre-induction; T1, before rocuronium injection; and T2, 1 min after rocuronium injection.
RESULTS
The Time50 ± standard deviation (SD) was 5.6 ± 3.7 s and 21.9 ± 5.6 s in the male and female patients, respectively. Based on the probit regression, the Time50 was 4.7 s (95% confidence interval [CI], 1.2-7.6 s) and 20.3 s (95% CI, 7.7-26.1 s) in the male and female patients, respectively. The Time95 was 10.6 s (95% CI, 7.7-25.3 s) and 35.0 s (95% CI, 28.1-95.5 s) in the male and female patients, respectively, with significantly higher values in females than in males (P < 0.001). Compared with the T0, MAP and HR decreased significantly at T1 and T2 in both groups.
CONCLUSION
The Time50 required for preventing rocuronium-induced withdrawal movement were 4.7 s and 20.3 s in male and female patients, respectively.
TRIAL REGISTRATION
This study was registered with the Chinese Clinical Trials Registry on April 7, 2021 (URL: http://www.chictr.org.cn . Registry number: ChiCTR2100045137 ) .
Topics: Adult; Alfentanil; Analgesics, Opioid; Arterial Pressure; Double-Blind Method; Female; Heart Rate; Humans; Male; Movement; Neuromuscular Nondepolarizing Agents; Pain; Prospective Studies; Rocuronium; Sex Factors; Time
PubMed: 35105302
DOI: 10.1186/s12871-022-01580-1 -
Frontiers in Pharmacology 2021The treatment of most severe COVID-19 patients included the large-scale use of sedatives and analgesics-possibly in higher doses than usual-which was reported in the... (Review)
Review
The treatment of most severe COVID-19 patients included the large-scale use of sedatives and analgesics-possibly in higher doses than usual-which was reported in the literature. The use of drugs that decrease mortality is necessary and opioids are important agents in procedures such as orotracheal intubation. However, these drugs seem to have been overestimated in the COVID-19 pandemic. We performed a review of the PubMed-Medline database to evaluate the use of opioids during this period. The following descriptors were used to enhance the search for papers: "Opioids", "COVID-19," "COVID-19 pandemic," "SARS-CoV-2," "Opioid use disorder," "Opioid dependence" and the names of the drugs used. We also evaluated the distribution of COVID-19 patients in Brazil and the applicability of opioids in our country during the COVID-19 pandemic. Several positive points were found in the use of opioids in the COVID-19 pandemic, for instance, they can be used for analgesia in orotracheal intubation, for chronic pain management, and as coadjutant in the management of acute intensification of pain. However, high doses of opioids might exacerbate the respiratory depression found in COVID-19 patients, their chronic use can trigger opioid tolerance and the higher doses used during the pandemic might result in greater adverse effects. Unfortunately, the pandemic also affected individuals with opioid use disorder, not only those individuals are at higher risk of mortality, hospitalization and need for ventilatory support, but measures taken to decrease the SARS-CoV-2 spread such as social isolation, might negatively affect the treatment for opioid use disorder. In Brazil, only morphine, remifentanil and fentanyl are available in the basic health care system for the treatment of COVID-19 patients. Out of the 5,273,598 opioid units used in this period all over the country, morphine, fentanyl, and remifentanil, accounted for, respectively, 559,270 (10.6%), 4,624,328 (87.6%), and 90,000 (1.8%) units. Many Brazilian regions with high number of confirmed cases of COVID-19 had few units of opioids available, as the Southeast region, with a 0.23 units of opioids per confirmed COVID-19 case, and the South region, with 0.05 units. In the COVID-19 pandemic scenario, positive points related to opioids were mainly the occurrence of analgesia, to facilitate intubation and their use as coadjutants in the management of acute intensification of pain, whereas the negative points were indiscriminate use, the presence of human immunosuppressor response and increased adverse effects due to higher doses of the drug. The importance of rational and individualized use of analgesic hypnotics and sedative anesthetics should be considered at all times, especially in situations of high demand such as the COVID-19 pandemic.
PubMed: 35069193
DOI: 10.3389/fphar.2021.758637 -
European Journal of Medical Research Jan 2021Intravenous opioids are administered for the management of visceral pain after laparoscopic surgery. Whether oxycodone has advantages over other opioids in the treatment... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Intravenous opioids are administered for the management of visceral pain after laparoscopic surgery. Whether oxycodone has advantages over other opioids in the treatment of visceral pain is not yet clear.
METHODS
In this study, the analgesic efficiency and adverse events of oxycodone and other opioids, including alfentanil, sufentanil, fentanyl, and morphine, in treating post-laparoscopic surgery visceral pain were evaluated. This review was conducted according to the methodological standards described in the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. The PubMed, Embase, and Cochrane databases were searched in December 2019.
RESULTS
Ten studies were included in this review. The sample size was 695 participants. The results showed that compared with morphine and fentanyl, oxycodone had a more potent analgesic efficacy on the first day after laparoscopic surgery, especially during the first 0.5 h. There was no significant difference in sedation between the two groups. Compared to morphine and fentanyl, oxycodone was more likely to lead to dizziness and drowsiness. Overall, patient satisfaction did not differ significantly between oxycodone and other opioids.
CONCLUSIONS
Oxycodone is superior to other analgesics within 24 h after laparoscopic surgery, but its adverse effects should be carefully considered.
Topics: Alfentanil; Analgesics, Opioid; Fentanyl; Humans; Laparoscopy; Morphine; Oxycodone; Pain; Pain Management; Sufentanil
PubMed: 33422129
DOI: 10.1186/s40001-020-00463-w -
BMC Pharmacology & Toxicology Jan 2023Regulations have broadened to allow moderate sedation administration for gastrointestinal endoscopy by non-anesthesia personnel. The line between moderate and deep...
PURPOSE
Regulations have broadened to allow moderate sedation administration for gastrointestinal endoscopy by non-anesthesia personnel. The line between moderate and deep sedation is ambiguous. Deep sedation offers patient comfort as well as greater safety concerns. Unintended deep sedation can occur if drug interactions are overlooked. We present a pharmacodynamic model for moderate sedation using midazolam, alfentanil and propofol. The model is suitable for training and devising rationales for appropriate dosing.
METHODS
The study consists of two parts: modeling and validation. In modeling, patients scheduled for esophagogastroduodenoscopy (EGD) or colonoscopy sedation are enrolled. The modified observer's assessment of alertness/sedation (MOAA/S) score < 4 is defined as loss of response to represent moderate sedation. Two patient groups receiving bronchoscopy or endoscopic retrograde cholangiopancreatography (ERCP) are used for validation. Model performance is assessed by receiver operating characteristic (ROC) curves and area under the curve (AUC). Simulations are performed to demonstrate how the model is used to rationally determine drug regimen for moderate sedation.
RESULTS
Interaction between propofol and alfentanil is stronger than the other pairwise combinations. Additional synergy is observed with three drugs. ROC AUC is 0.83 for the modeling group, and 0.96 and 0.93 for ERCP and bronchoscopy groups respectively. Model simulation suggests that 1 mg midazolam, 250 µg alfentanil and propofol maximally benefits from drug interactions and suitable for moderate sedation.
CONCLUSION
We demonstrate the accurate prediction of a three-drug response surface model for moderate sedation and simulation suggests a rational dosing strategy for moderate sedation with midazolam, alfentanil and propofol.
Topics: Humans; Midazolam; Alfentanil; Propofol; Conscious Sedation; Endoscopy, Gastrointestinal
PubMed: 36647160
DOI: 10.1186/s40360-023-00642-5 -
ACS Omega May 2022The ongoing public health emergency of opioid use disorders (OUD) and overdose in the United States is largely driven by fentanyl and its related analogues and has...
The ongoing public health emergency of opioid use disorders (OUD) and overdose in the United States is largely driven by fentanyl and its related analogues and has resulted in over 75 673 deaths in 2021. Immunotherapeutics such as vaccines have been investigated as a potential interventional strategy complementary to current pharmacotherapies to reduce the incidence of OUD and opioid-related overdose. Given the importance of targeting structurally distinct fentanyl analogues, this study compared a previously established lead conjugate vaccine (F-CRM) to a series of novel vaccines incorporating haptens derived from alfentanil and acetylfentanyl (F), and evaluated their efficacy against drug-induced pharmacological effects in rats. While no vaccine tested provided significant protection against alfentanil, lead formulations were effective in reducing antinociception, respiratory depression, and bradycardia elicited by fentanyl, sufentanil, and acetylfentanyl. Compared with control, vaccination with F-CRM also reduced drug levels in the brain of rats challenged with lethal doses of fentanyl. These data further support investigation of F-CRM as a candidate vaccine against fentanyl and selected analogues.
PubMed: 35601290
DOI: 10.1021/acsomega.2c00820 -
BMC Anesthesiology Jun 2023Although the operation time of hysteroscopy is short, the incidence of postoperative nausea and vomiting is high. The aim of this study was to compare the incidence of... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Although the operation time of hysteroscopy is short, the incidence of postoperative nausea and vomiting is high. The aim of this study was to compare the incidence of postoperative nausea and vomiting in hysteroscopy when remimazolam is combined with remifentanil or alfentanil.
METHODS
We conducted a randomized, controlled, double-blind trial. Patients undergoing hysteroscopy were recruited and randomly assigned to either the remimazolam-remifentanil (Group RR) or the remimazolam-alfentanil group (Group RA). All patients in the two groups were started with an induction dose of remimazolam besylate 0.2 mg/kg and then maintained with a dosage of 1.0 mg/kg/h. After induction with remimazolam besylate, in Group RR, remifentanil was infused using a target-controlled infusion system with a target concentration of 1.5 ng/ml and titrated throughout the procedure. In Group RA, infusion of alfentanil was started with an initial bolus dose of 20 µg/kg over 30 s and then maintained at an initial rate of 0.16 µg/kg/min. The primary observation outcome was the incidence rate of postoperative nausea and vomiting. The secondary observation outcomes were the time to awakening, the length of stay in the PACU, the total remimazolam dose and adverse effects, such as low SpO, bradycardia, hypotension and body movement.
RESULTS
A total of 204 patients were successfully included in this study. The incidence of postoperative nausea and vomiting in Group RR (2/102, 2.0%) was significantly lower than that in Group RA (12/102, 11.8%) (p < 0.05). There was no significant difference in the incidence of adverse events, such as low SpO, bradycardia, hypotension and body movement, between Groups RR and RA (p > 0.05).
CONCLUSIONS
Remimazolam-remifentanil causes less postoperative nausea and vomiting than remimazolam-alfentanil in hysteroscopy.
TRIAL REGISTRATION
Clinical trial registration number: ChiCTR2100044177. Full date of the first registration: 12/03/2021.
Topics: Humans; Female; Pregnancy; Postoperative Nausea and Vomiting; Alfentanil; Remifentanil; Bradycardia; Hysteroscopy; Hypotension
PubMed: 37308843
DOI: 10.1186/s12871-023-02164-3 -
Spinal Cord Series and Cases Jul 2022Systematic review.
STUDY DESIGN
Systematic review.
OBJECTIVES
This systematic review evaluates all randomized clinical trials (RCTs) conducted on assessing the efficacy and safety of pharmacologic therapies for the treatment of Spinal Cord Injury (SCI)-associated pain.
METHODS
The PubMed/Medline, EMBASE, and Cochrane library online databases were searched from 1946 to May 2019 using specific search terms for SCI, pain, and RCTs meeting predetermined inclusion criteria. The efficacy outcome of interest was pain reduction, discontinuations, and adverse events (AEs).
RESULTS
Of 2746 records identified through database searching, 703 duplicates were deleted. 1814 were excluded, the full text of the remaining 230 articles was reviewed, and finally, 28 papers were selected for drafting. The most studied medications were pregabalin, gabapentin, amitriptyline, and ketamine. Pregabalin, gabapentin, and amitriptyline reduced VAS by more than 30%, and ketamine reduced VAS by 40%. Oxcarbazepine, lamotrigine, alfentanil, tramadol, and morphine added to clonidine, baclofen, and botulinum toxin type A (BTA) significantly reduced pain compared with placebo. On the other hand, valproate, levetiracetam, trazodone, and duloxetine did not significantly alleviate SCI-associated pain compared to placebo. The risks of AEs and discontinuations in anticonvulsants were the least, while it was highest in analgesics.
CONCLUSIONS
Studies of SCI-associated pain were few, small, heterogenic in measures and values, and did not allow quantitative comparisons of efficacy. However, available data suggested pregabalin and gabapentin led to a more marked reduction in SCI-associated pain with fewer AEs. Additional clinical studies are needed to assess the effect of established and novel management options.
Topics: Amitriptyline; Anticonvulsants; Gabapentin; Humans; Ketamine; Pain; Pregabalin; Spinal Cord Injuries
PubMed: 35788127
DOI: 10.1038/s41394-022-00529-3 -
BMC Anesthesiology Nov 2022Opioid-reduced anesthesia may accelerate postoperative rehabilitation by reducing opioid-related side effects. The objective was to investigate the feasibility of... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Opioid-reduced anesthesia may accelerate postoperative rehabilitation by reducing opioid-related side effects. The objective was to investigate the feasibility of opioid-reduced general anesthesia based on esketamine and to observe postoperative nausea and vomiting (PONV), postoperative pain, hemodynamics and other adverse reactions in gynecological day surgery compared with the traditional opioid-based anesthesia program.
METHOD
This study was conducted as a prospective parallel-group randomized controlled trial. A total of 141 adult women undergoing gynecological day surgery were included. Patients were randomly assigned to receive traditional opioid-based anesthesia (Group C) with alfentanil, or opioid-reduced anesthesia (a moderate-opioid group (Group MO) and low-opioid group (Group LO) with esketamine and alfentanil). For anesthesia induction, the three groups received 20, 20, 10 μg/kg alfentanil respectively and Group LO received an additional 0.2 mg/kg esketamine. For maintenance of anesthesia, the patients in Group C received 40 μg/kg/h alfentanil, and those in Group MO and Group LO received 0.5 mg/kg/h esketamine.
RESULTS
Patients in the three groups had comparable clinical and surgical data. A total of 33.3% of patients in Group C, 18.4% of patients in Group MO and 43.2% of patients in Group LO met the primary endpoint (p = 0.033), and the incidence of nausea within 24 hours after surgery in Group MO was lower than in Group LO (p < 0.05). The extubation time, median length of stay in the hospital after surgery and visual analog scale (VAS) of postoperative pain were equivalent in the three groups. The frequencies of adverse hemodynamic events in the MO 1(0, 2) and LO 0(0, 1) groups were significantly decreased (p < 0.05). Compared with Group C, the median length of stay in the postanesthesia care unit (PACU) in Group LO was increased, 60.0 (36.25, 88.75) vs. 42.5 (25, 73.75) minutes (p < 0.05).
CONCLUSIONS
Opioid-reduced anesthesia based on esketamine is feasible and provides effective analgesia for patients. Esketamine provided a positive analgesic effect and the opioid-reduced groups showed more stable hemodynamics. However, less or no use of opioids did not result in a more comfortable prognosis.
TRIAL REGISTRATION
This study was registered at Chictr.org.cn (NO. ChiCTR2100053153 ); November 13, 2021.
Topics: Adult; Humans; Female; Analgesics, Opioid; Ambulatory Surgical Procedures; Alfentanil; Prospective Studies; Pain, Postoperative; Anesthesia, General
PubMed: 36384481
DOI: 10.1186/s12871-022-01889-x -
Drug Design, Development and Therapy 2024Cough is one of the most common complications following intravenous administration of sufentanil during anesthesia induction. The study aimed to investigate the... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Cough is one of the most common complications following intravenous administration of sufentanil during anesthesia induction. The study aimed to investigate the protective effect of alfentanil, afentanyl derivative with short onset time and short duration, in reducing sufentanil-induced cough.
PATIENTS AND METHODS
Eighty patients that scheduled for thyroid surgery under general anesthesia were randomly divided into the alfentanil group and normal saline group, with 40 cases per group. Patients in the alfentanil group received intravenous administration of 2 μg/kg alfentanil prior to sufentanil injection during general anesthesia induction, while the same dose of normal saline was administered in the normal saline group. The outcomes measures included the incidence and severity of cough and common side effects of opioids following the administration of sufentanil during the induction of general anesthesia, intraoperative hemodynamics parameters and major adverse events during anesthesia recovery period.
RESULTS
The incidence of cough within one minute after the injection of sufentanil during anesthesia induction was 40% in the normal saline group, and the pretreatment of alfentanil significantly reduced the incidence of sufentanil-induced cough to 5% (p < 0.05). Correspondingly, the patients in the alfentanil group had decreased severity of sufentanil-induced cough compared with the normal saline group (p < 0.05). No significant differences in the incidences of common side effects of opioids (dizziness, nausea and vomiting, chest tightness and respiratory depression) within one minute after sufentanil injection were found (p > 0.05). Furthermore, there were no significant differences between the two groups in intraoperative hemodynamic parameters, extubation time, or the incidences of emergence agitation, respiratory depression, delayed recovery from anesthesia and postoperative nausea and vomiting during Postanesthesia Care Unit stay (p > 0.05).
CONCLUSION
Pretreatment with low-dose alfentanil (2 μg/kg) effectively and safely reduced both the incidence and severity of sufentanil-induced cough during anesthesia induction.
CLINICAL TRIAL REGISTRATION NUMBER
Chinese Clinical Trial Registry (identifier: ChiCTR2300069286).
Topics: Adult; Female; Humans; Male; Middle Aged; Alfentanil; Analgesics, Opioid; Anesthesia, General; Cough; Dose-Response Relationship, Drug; Double-Blind Method; Prospective Studies; Sufentanil
PubMed: 38774482
DOI: 10.2147/DDDT.S464823