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Annals of Plastic Surgery May 2023This study aims to observe the safety and effectiveness of remimazolam benzenesulfonate combined with alfentanil for painless and comfort anesthesia in plastic surgery. (Clinical Trial)
Clinical Trial
OBJECTIVE
This study aims to observe the safety and effectiveness of remimazolam benzenesulfonate combined with alfentanil for painless and comfort anesthesia in plastic surgery.
METHODS
Two hundred patients with American Society of Anesthesiologists (ASA) I-II for elective facial autologous lipofilling + autologous liposuction (thigh or abdomen) plastic surgery in our hospital were selected. One hundred patients received comfort anesthesia (observation group) on odd-numbered day of surgery, and other 100 patients received painless anesthesia (control group) on even-numbered day. Patients in both groups were given slow injection of remimazolam benzenesulfonate 0.1 mg/kg and alfentanil 5 μg/kg to induce sleep before local anesthesia. Depending on body action reaction to surgical stimulation, patients in the observation group were received with remimazolam 0.05 mg/kg and alfentanil 2.5 μg/kg for maintenance until the end of surgery after local anesthesia, and patients in the control group received with remimazolam 0.25 to 0.5 mg/kg/h and alfentanil 25 to 50 μg/kg/h in continuous pumps. Time to fall asleep, sedation score, time to end of medication, time to open eyes, recovery score, and the presence of body movement, glossoptosis, arousal or jaw support during hypoxia, hypotension, bradycardia, operation time, total amount of remimazolam and alfentanil used, and the presence of postoperative complications such as pruritus, dizziness, nausea, and vomiting were recorded in both 2 groups.
RESULTS
There were no significant differences in the preoperative vital sign parameters as mean arterial pressure, heart rate, and oxygen saturation between 2 groups ( P > 0.05). Intraoperative mean arterial pressure and heart rate were significantly lower in both groups compared with preoperative ( P < 0.05), but there was no statistically significant between the 2 groups ( P > 0.05). There was no significant decrease in oxygen saturation in both groups under the condition of intraoperative oxygen inhalation ( P > 0.05). There was no significant difference between the 2 groups in the incidence of adverse reactions, such as intraoperative body movement induced by skin cutting, glossoptosis requiring jaw thrust, postoperative pruritus, dizziness, nausea, and vomiting ( P > 0.05). There was no statistically significant difference in time to fall asleep, sedation score during local anesthesia, time to open eyes after stopping anesthetics, and recovery score between the 2 groups ( P > 0.05). Meanwhile, the total amount of remimazolam and alfentanil use was significantly reduced in patients in the observation group compared with the control group ( P < 0.05).
CONCLUSIONS
Remimazolam benzenesulfonate combined with alfentanil can be used as a comfort anesthesia and painless anesthesia protocol in plastic surgery, which has the advantages of rapid onset of action, safety and comfort for patients, rapid recovery, and good cooperation. Furthermore, the protocol of remimazolam benzenesulfonate combined with alfentanil used in the observation group can significantly reduce the total amount of remimazolam and alfentanil used.
Topics: Humans; Alfentanil; Anesthesia, Local; Benzenesulfonates; Dizziness; Glossoptosis; Nausea; Propofol; Surgery, Plastic; Vomiting
PubMed: 36752399
DOI: 10.1097/SAP.0000000000003377 -
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 -
La Tunisie MedicaleCataract is a ubiquitous pathology. Its prevalence increases with age. Nowadays, cataract surgery is increasingly performed on an outpatient basis under locoregional... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Cataract is a ubiquitous pathology. Its prevalence increases with age. Nowadays, cataract surgery is increasingly performed on an outpatient basis under locoregional anesthesia. In this context, sedation-analgesia is essential but not without risks.
AIM
To evaluate the effectiveness of premedication with melatonin on intraoperative sedation-analgesia.
METHODS
This is a prospective randomized double-blind study including patients proposed for scheduled cataract surgery by phacoemulsification under peribulbar anesthetic block. The participants will be randomized into two groups: group (M) will receive 05 tablets of melatonin (10mg sublingual) and group (P) will receive 05 tablets of Sucralose sublingually. Perioperative sedation-analgesia will be evaluated by the Ramsey score, the bisectral index, the simple verbal scale (EVS) and by the perioperative consumption of midazolam and alfentanyl. Secondary endpoints will be the degree of preoperative anxiety (Amsterdam Preoperative, Anxiety and Information Scale), the perioperative tonus of the eyeball, intraoperative nicardepine consumption and patients and surgeons satisfaction. A value of p <0.05 will be considered statistically significant.
EXPECTED RESULTS
The administration of melatonin as a premedication for scheduled cataract surgery will allow a better quality of intraoperative sedationanalgesia, a reduction in the doses consumed of midazolam and alfentanyl, improves surgical conditions, leads to a decrease in ocular tone, and optimizes surgical safety conditions for the patient.
Topics: Humans; Midazolam; Melatonin; Double-Blind Method; Alfentanil; Prospective Studies; Premedication; Cataract
PubMed: 36571756
DOI: No ID Found -
Anaesthesia May 2023Propfol-remifentanil-based total intravenous anaesthesia has dominated recent clinical practice due to its favourable pharmacokinetic profile. Interruption in... (Review)
Review
Propfol-remifentanil-based total intravenous anaesthesia has dominated recent clinical practice due to its favourable pharmacokinetic profile. Interruption in remifentanil supply has presented an opportunity to diversify or even avoid the use of opioids and consider adjuncts to propofol-based total intravenous anaesthesia. Propofol, while a potent hypnotic, is not an effective analgesic. The administration of opioids, along with other adjuncts such as α-2 adrenoceptor agonists, magnesium, lidocaine, ketamine and nitrous oxide provide surgical anaesthesia and avoids large doses of propofol being required. We provide an overview of both target-control and manual infusion regimes for the alternative opioids: alfentanil, sufentanil and fentanyl. The optimal combination of hypnotic-opioid dose, titration sequence and anticipated additional postoperative analgesia required depend on the chosen combination. In addition, we include a brief discussion on the role of non-opioid adjuncts in total intravenous anaesthesia, suggested doses and expected reduction in propofol dose.
Topics: Humans; Remifentanil; Propofol; Anesthesia, Intravenous; Piperidines; Analgesics, Opioid; Anesthesia, General; Hypnotics and Sedatives; Anesthetics, Intravenous
PubMed: 36562193
DOI: 10.1111/anae.15952 -
Aesthetic Plastic Surgery Jun 2023Comfort and recovery are major concerns of patients seeking aesthetic surgery. This study aimed to assess postoperative pain and recovery after outpatient breast surgery...
BACKGROUND
Comfort and recovery are major concerns of patients seeking aesthetic surgery. This study aimed to assess postoperative pain and recovery after outpatient breast surgery under sedation, intercostal block, and local anaesthesia.
METHODS
This prospective cohort study included all consecutive patients who underwent aesthetic breast surgery between April 2021 and August 2022. Epidemiological data, anaesthesia, pain, and patients' satisfaction were systematically assessed with standardized self-assessment questionnaires.
RESULTS
Altogether, 48 patients [median (IQR) age: 30 (36-25)] were included. The most frequent surgery was mastopexy. 69% of surgeries involved additional procedures. The mean intercostal block and local anaesthesia time was 15 min. Patients received a median (IQR) of 19 (34-2) mg/kg lidocaine and 2.3 (2.5-2.0) mg/kg ropivacaine. The median (IQR) consumption of propofol and alfentanil was, respectively, 4.89 (5.48-4.26) mg/kg/h and 0.27 (0.39-0.19) µg/kg/min. No conversion to general anaesthesia or unplanned hospital admission occurred. Patients were discharged after a median (IQR) of 2:40 (3:43-1:58) hours. Within the first 24 postoperative hours, 17% required once an antiemetic medication and 38% an opioid. Patients were very satisfied with the anaesthesia and 90% of the patients had not wished more analgesia in the first 24 h.
CONCLUSIONS
Aesthetic breast surgery under sedation, intercostal block, and tumescent anaesthesia can safely be performed as an ambulatory procedure and is associated with minimal intra- and postoperative opioid consumption and high patient satisfaction. These data may be used to inform patients and clinicians and improve the overall quality of care.
LEVEL OF EVIDENCE IV
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Topics: Humans; Adult; Female; Prospective Studies; Analgesics, Opioid; Anesthesia, Local; Esthetics; Breast Neoplasms
PubMed: 36544050
DOI: 10.1007/s00266-022-03214-w -
Journal of Opioid Management 2022To determine equianalgesic potency ratios for opioids with an -evidence-based approach without the use of pre-existing potency tables. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To determine equianalgesic potency ratios for opioids with an -evidence-based approach without the use of pre-existing potency tables.
DESIGN
Frequentist network meta-analysis (NMA) of randomized controlled trials (RCTs) comparing opioids in patient-controlled analgesia (PCA).
SETTING
A systematic review.
DATA SOURCES
A systematic search of MEDLINE, EMBASE, the Cochrane Library (CENTRAL), and Web of Science identified relevant RCTs from start of recording to 2019.
ELIGIBILITY CRITERIA
RCTs comparing opioids via intravenous PCA in acute pain, with comparable resulting pain scores and identical treatment with coanalgesics at study level. The quality of studies was assessed using the Cochrane risk of bias tool with six items.
RESULTS
52 RCTs were identified with data for 16 opioids. Primary endpoint was the inverted ratio of means of the total consumption administered via PCA, which resembles the analgesic potency. The calculated analgesic potencies were sufentanil 423 [95 percent CI 334.99; 532.96], fentanyl 58 [48.22; 68.60], buprenorphine 37 [26.66; 50.81], remifentanil 13 [9.37; 19.13], alfentanil 7 [4.02; 11.01], hydromorphone 6 [4.96; 8.43], oxymorphone 6 [4.46; 8.84], butorphanol 4.5 [3.05; 6.73], diamorphine 2.2 [1.16; 4.10], morphine 1, oxycodone 0.9 [0.65; 1.34], piritramide 0.9 [0.55; 1.56], nalbuphine 0.7 [0.54; 0.95], pethidine 0.12 [0.10; 0.15], meptazinol 0.08 [0.03; 0.20], and tramadol 0.08 [0.07; 0.10].
CONCLUSIONS
The results in part contradict the values from the literature, which have been criticized for their imprecision. From clinical experience however, our findings seem very plausible. Short-acting opioids are less potent compared to longer acting drugs, eg, morphine, probably due to shorter intervals for -readministration.
Topics: Humans; Analgesia, Patient-Controlled; Analgesics, Opioid; Network Meta-Analysis; Tramadol; Morphine
PubMed: 36523208
DOI: 10.5055/jom.2022.0751 -
Journal of Anesthesia Apr 2023Propofol can be used alone or in combination with opioids during gastroscopy. This study aimed to assess the efficacy and safety of intravenous propofol and different... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
Propofol can be used alone or in combination with opioids during gastroscopy. This study aimed to assess the efficacy and safety of intravenous propofol and different doses of alfentanil in patients undergoing gastroscopy.
METHODS
A total of 300 patients undergoing sedative gastroscopy were randomly divided into four groups, and 0.9% saline (group A), 2 μg/kg alfentanil (group B), 3 μg/kg alfentanil (group C) or 4 μg/kg alfentanil (group D) were injected intravenously 1 min before the intravenous injection of 1.5 mg/kg propofol. If body movement and coughing occurred during the procedure, 0.5 mg/kg propofol would be administered intravenously. The primary outcome (awakening time) and secondary outcomes were recorded and analyzed, including hemodynamic changes, the incidences of body movement, coughing, hypoxemia, hypotension, hypertension, bradycardia, tachycardia, nausea and vomiting, drowsiness and dizziness.
RESULTS
Patients in group C (7.0 [5.0 to 8.0] min) and group D (6.0 [5.0 to 7.0] min) woke up significantly earlier than those in group A (8.0 [6.0 to 10.0] min) (P < 0.001). Patients in group A experienced more body movement (P = 0.001) and coughing (P < 0.001) than the other groups. With the increasing dose of alfentanil, the morbidity of hypotension and bradycardia increased significantly (P = 0.001), while the incidence of dizziness decreased significantly (P = 0.037). The incidences of hypoxemia, tachycardia, drowsiness, nausea and vomiting were similar among the four groups (P > 0.05).
CONCLUSIONS
Intravenous 1.5 mg/kg propofol combined with 3 μg/kg alfentanil is more suitable for patients undergoing gastroscopy, and the dose of alfentanil can be reduced according to the patient's actual physical condition.
Topics: Humans; Propofol; Alfentanil; Anesthetics, Intravenous; Gastroscopy; Bradycardia; Dizziness; Nausea; Vomiting; Hypoxia; Hypotension
PubMed: 36482231
DOI: 10.1007/s00540-022-03145-5 -
Drug Design, Development and Therapy 2022Propofol is widely used for sedation of hysteroscopy. It can cause injection pain, respiratory depression, and hypotension. Remimazolam is a novel ultra-short-acting... (Randomized Controlled Trial)
Randomized Controlled Trial Clinical Trial
BACKGROUND
Propofol is widely used for sedation of hysteroscopy. It can cause injection pain, respiratory depression, and hypotension. Remimazolam is a novel ultra-short-acting benzodiazepine. Clinical practice has found that the use of remimazolam alone often leads to body movement during hysteroscopy, which decreases the safety and comfort. Here this study is to investigate whether remimazolam combined with low-dose propofol can improve the sedation effect and safety of hysteroscopy.
PATIENTS AND METHODS
In this prospective, randomized, parallel-controlled trial, women (18 to 60 years) undergoing hysteroscopy were randomly assigned to receive propofol (Group P), remimazolam tosylate (Group R), or remimazolam tosylate plus propofol (Group RP). Intraoperative sedation depth was kept at the bispectral index (BIS) value of 40-60. 6 μg/kg alfentanil was used for analgesic before sedation. Intraoperative low pulse oxygen saturation (SpO), body movement, injection pain, mean arterial pressure (MAP), heart rate (HR), and postoperative recovery time, dizziness, nausea and vomiting were recorded and compared.
RESULTS
From February to July 2022, 193 patients were recruited and randomly assigned to group P (n=64), group R (n=64), or group RP (n=65). There was no significant inter-group difference of the intraoperative BIS values. The incidence of low SpO, injection pain, hypotension, and postoperative dizziness in group RP were less than that in group P, and had no significant difference from group R. The incidence of body movement in group RP was less than that in group R, and had no significant difference from group P. Postoperative recovery time of group RP was shorter than that of the other two groups. No significant inter-group difference in bradycardia, nausea and vomiting was observed.
CONCLUSION
Remimazolam tosylate combined with low dose of propofol improved sedation and safety in hysteroscopy, and may be a more ideal sedative method for hysteroscopy.
Topics: Humans; Female; Pregnancy; Propofol; Hysteroscopy; Prospective Studies; Dizziness; Benzodiazepines; Hypnotics and Sedatives; Hypotension; Pain; Vomiting; Nausea
PubMed: 36471692
DOI: 10.2147/DDDT.S390403 -
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 -
Frontiers in Pharmacology 2022Sedation is recommended by most guidelines to be offered to all patients undergoing diagnostic flexible bronchoscopy (DFB) without contraindications, and the most...
Sedation is recommended by most guidelines to be offered to all patients undergoing diagnostic flexible bronchoscopy (DFB) without contraindications, and the most commonly reported regimen is midazolam in combination with a short-acting opioid (fentanyl or alfentanil) to provide both sedative and antitussive effects. However, the optimal dose or ideal regimen of the combination therapy with midazolam and opioids has not yet been found. So this randomized, double-blinded clinical trial was designed and registered (ChiCTR2100049052) to assess the safety and efficacy of midazolam combined with different doses of alfentanil in DFB sedation. Our study showed that relative high doses of alfentanil (10-25 μg/kg) combined with a fixed low dose of midazolam can markedly reduce hemodynamic fluctuations, cough reactions, patients' discomforts, and improve their satisfaction in a dose-dependent manner during DFB, with no significant increase in the desaturation risks.
PubMed: 36339547
DOI: 10.3389/fphar.2022.1036840