Effect of Dexamethasone on the Action of Sugammadex

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02510157

Enrollment

Registered

2015-07-29

Start date

2015-05-31

Completion date

2016-09-30

Last updated

2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

sugammadex, dexamethasone, neuromuscular blockade

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.

Interventions

DRUGDexamethasone

active comparator

DRUGNormal Saline

placebo controlled intervention

DRUGsugammadex

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Other

Measure	Time frame	Description
Time from end of surgery to extubation of patient	minutes after administration of sugammadex (0 to 30 minutes)	measurement of time after administration of the reversal agent (sugammadex) to achieve extubation of patient (up to 30 minutes)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026