Effect of Dexamethasone on the Action of Sugammadex

Not Applicable

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Drug: Dexamethasone; Drug: Normal Saline; Drug: sugammadex

• Registration Number: NCT02510157
• Lead Sponsor: Attikon Hospital

Brief Summary

This study aims to investigate the possible clinical effect of dexamethasone on the action of sugammadex when it is administered to reverse deep neuromuscular blockade caused by rocuronium in laparoscopic cholecystectomies.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-16
• Study First Submitted QC: 2015-07-26
• Study First Posted: 2015-07-29
• Status Verified: 2016-07
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-10-02
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• patients aged 18-70 years
• laparoscopic cholecystectomy
• operation < 3 hours

Exclusion Criteria

• age <18 or >70 years old
• ASA physical status >3
• central nervous system diseases
• severe psychiatric disorders under treatment
• cognitive dysfunction
• known or suspected allergy to the administered drugs
• operations > 3 hours
• surgical intraoperative complications-open cholecystectomy
• severe renal or liver disease
• diabetes melitus
• immunosuppressed patients
• chronic immunosuppresant therapy (corticosteroids or other drugs)
• all contraindications to corticosteroids administration
• patiens on chronic use of opioids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexamethasone	Dexamethasone	Dexamethasone is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.
dexamethasone	sugammadex	Dexamethasone is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.
normal saline	Normal Saline	Normal saline is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.
normal saline	sugammadex	Normal saline is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.

Primary Outcome Measures

Name	Time	Method
Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex	minutes after administration of sugammadex (0 to 30 minutes)	measurement of time after administration of the reversal agent (sugammadex) to achieve train-of-four (TOF0 ratio of 0.9 (up to 30 minutes)

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	1, 6, 12, 24 hours postoperatively	Assessed by Numeric Rating Scale 0-10
Postoperative nausea and vomiting	1, 6, 12, 24 hours postoperatively	Assessed by nausea/vomiting scale (11. Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth 2012; 108: 423-429)

Trial Locations

Locations (1)

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.; 🇬🇷 Athens, Greece