Effect of Dexamethasone on the Action of Sugammadex

Study Overview
=================
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.

Conditions
-----------------
Neuromuscular Blockade

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Normal Saline
* Drug: sugammadex


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexamethasone<br>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. | Drug: Dexamethasone<br>* active comparator<br>Drug: sugammadex<br>* sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery<br>|
| Placebo Comparator: normal saline<br>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. | Drug: Normal Saline<br>* placebo controlled intervention<br>* Other names: N/S 0.9%;Drug: sugammadex<br>* sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex | measurement of time after administration of the reversal agent (sugammadex) to achieve train-of-four (TOF0 ratio of 0.9 (up to 30 minutes) | minutes after administration of sugammadex (0 to 30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Assessed by Numeric Rating Scale 0-10 | 1, 6, 12, 24 hours postoperatively | 
| Postoperative nausea and vomiting | 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) | 1, 6, 12, 24 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sugammadex, dexamethasone, neuromuscular blockade