Effect of Dexamethasone on the Action of Sugammadex

Attikon Hospital44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Neuromuscular Blockade

Interventions

DexamethasoneDRUG

active comparator

Normal SalineDRUG

placebo controlled intervention

sugammadexDRUG

sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Athens, Greece

Outcomes

Primary Outcomes

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)

Time frame: minutes after administration of sugammadex (0 to 30 minutes)

Secondary Outcomes

Postoperative pain

Assessed by Numeric Rating Scale 0-10

Time frame: 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)

Time frame: 1, 6, 12, 24 hours postoperatively

Data from ClinicalTrials.gov

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