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Is there an interaction between dexamethasone and sugammadex in real clinical conditions? A randomized controlled trial in patients undergoing laparoscopic cholecystectomy.

ABSTRACT: Background and Aims:There is evidence that sugammadex can encapsulate other substances except rocuronium, such as dexamethasone. The aim of this study was to investigate the possible clinical interaction between dexamethasone and sugammadex, in patients undergoing laparoscopic cholecystectomy. Material and Methods:This was a randomized, double-blind controlled trial, performed in patients aged 18-75 years, American Society of Anesthesiologists (ASA) I-III, who underwent a laparoscopic cholecystectomy under deep neuromuscular blockade with rocuronium. Patients received 5 mg of dexamethasone or placebo (N/S 0.9%) during induction of anesthesia. Sugammadex 4 mg/kg was administered at the end of surgery at post-tetanic count 1-2. The outcome measures assessed were the time from sugammadex administration until train-of-four (TOF) 0.9, and until patient's extubation, postoperative pain (measured by numeric rating scale 0-10), nausea and vomiting, as well as rescue analgesics and antiemetics required during the first 24 hours postoperatively. The total dose of rocuronium required in both groups was also recorded. Results:Overall, 44 patients were studied. No difference was detected regarding the demographic and surgical characteristics of patients. The time from sugammadex administration until TOF 0.9 and until patients' extubation did not differ significantly between the groups (P = 0.21 and 0.17). Operating conditions, pain scores, nausea/vomiting, and rescue analgesics and antiemetics during the first 24 hours postoperatively, did not differ between the groups. The total dose of rocuronium, however, was significantly more in patients who received dexamethasone (P = 0.01). Conclusion:No significant clinical interaction was revealed between dexamethasone and sugammadex during reversal of deep neuromuscular blockade in patients undergoing laparoscopic cholecystectomy.

SUBMITTER: Batistaki C

PROVIDER: S-EPMC6598587 | biostudies-literature | 2019 Apr-Jun

REPOSITORIES: biostudies-literature

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Is there an interaction between dexamethasone and sugammadex in real clinical conditions? A randomized controlled trial in patients undergoing laparoscopic cholecystectomy.

Batistaki Chrysanthi C Pandazi Aggeliki A Kyttari Aikaterini A Kaminiotis Evangelia E Kostopanagiotou Georgia G

Journal of anaesthesiology, clinical pharmacology 20190401 2

<h4>Background and aims</h4>There is evidence that sugammadex can encapsulate other substances except rocuronium, such as dexamethasone. The aim of this study was to investigate the possible clinical interaction between dexamethasone and sugammadex, in patients undergoing laparoscopic cholecystectomy.<h4>Material and methods</h4>This was a randomized, double-blind controlled trial, performed in patients aged 18-75 years, American Society of Anesthesiologists (ASA) I-III, who underwent a laparosc ...[more]

PMID: 31303711

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Project description:BackgroundRecent meta-analyses concluded that antibiotic prophylaxis is not warranted in low-risk laparoscopic cholecystectomy. However, most trials in the meta-analyses had a relatively small sample size and were statistically underpowered. In addition, many of the trials mentioned potential cost savings owing to the elimination of prophylactic antibiotics. However, no trial has statistically estimated the cost effectiveness. To evaluate the results of meta-analyses, we conducted a randomized controlled trial on the role of prophylactic antibiotics in low-risk laparoscopic cholecystectomy with an adequate sample size.MethodsFrom March 2007 to May 2013, at the Department of Surgery, Kansai Medical University, patients who were scheduled for elective laparoscopic cholecystectomy were randomly assigned to one of two arms: those who were and were not administered prophylactic antibiotics. The primary endpoint was the occurrence of postoperative infections and secondary endpoints were postoperative hospital stay and medical costs.FindingsDuring the study period, 518 patients were assigned to the Antibiotics group and 519 to the No antibiotics group. Occurrences of surgical site infections, distant infections and overall infections were significantly lower in the Antibiotics group than in the No antibiotics group (0.8 vs. 3.7%, p?=?0.001, OR: 0.205 (95%CI: 0.069 to 0.606); 0.4 vs. 3.1%, p?=?0.0004, OR: 0.122 (95%CI: 0.028 to 0.533); 1.2 vs. 6.7%; p<0.0001, OR: 0.162 (95%CI: 0.068 to 0.389), respectively). The postoperative hospital stay was significantly shorter in the Antibiotics group (mean, SD: 3.69±1.56 vs. 4.07±3.00; p?=?0.01) and the postoperative medical costs were significantly lower in the Antibiotics group (mean, SD: $766±341 vs. 832±670; p?=?0.047). Multivariable analysis showed that independent risk factors for postoperative infectious complications were no prophylactic antibiotics (p<0.0001) and age 65 or older (p?=?0.006).ConclusionsPerioperative administration of prophylactic antibiotics should be recommended in laparoscopic cholecystectomy to prevent postoperative infectious complications and to reduce medical costs.Trial registrationUMIN Clinical Trials Registry UMIN000003749.

Project description:Background: The pain pattern after laparoscopic cholecystectomy (LC) is complex and distinct from postoperative pain after other laparoscopic procedures, suggesting that procedure-specific optimal analgesic management plans should be proposed. Duloxetine, a non-opioid neuromodulator, has been widely used to manage pain with dual central and peripheral analgesic properties. Aims: To assess the effect of preoperative administration of duloxetine compared to placebo on postoperative pain control in patients undergoing LC. Patients and Methods: This study was a randomized, parallel-group, placebo-controlled, double-blinded study performed on patients undergoing LC. Patients were randomly divided into two groups of 30 each on the day of surgery in the preoperative holding area, using a computer-generated random number to receive 60 mg duloxetine as a single oral dose 2 h before the procedure or placebo. The primary outcome was the difference in the mean of visual analogue scale (VAS) scores between the two studied groups, as measured by the area under the curve (AUC) of the VAS scores. Results: The derived AUC of VAS scores in the duloxetine group (757.89 ± 326.01 mm × h) was significantly lower than that calculated for the control group (1005.1 ± 432.5 mm × h). The mean postoperative VAS scores recorded at 4 and 24 h were statistically different between the study groups (p = 0.041 and 0.003, respectively). As observed in the survival curve analysis, there was no significant difference (p = 0.665) for the time until the patient's first request for rescue medications in the two groups. The frequency of postoperative nausea and vomiting (PONV) was lower in patients of the duloxetine group than that recorded in those allocated to the control group at 8 and 24-h time intervals (p = 0.734 and 0.572, respectively). Conclusion: Preoperative use of duloxetine reduces postoperative pain significantly compared with placebo. In addition, its use is associated with a reduction in PONV. These preliminary findings suggest that duloxetine could play a role in the acute preoperative period for patients undergoing LC. Clinical Trial Registration: [https://clinicaltrials.gov/ct2/show/NCT05115123, identifier NCT05115123].

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Is there an interaction between dexamethasone and sugammadex in real clinical conditions? A randomized controlled trial in patients undergoing laparoscopic cholecystectomy.

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Is there an interaction between dexamethasone and sugammadex in real clinical conditions? A randomized controlled trial in patients undergoing laparoscopic cholecystectomy.

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