Effect of Dexamethasone on the Action of Sugammadex

NCT02510157 | Completed

• 1 other identifier: 711/19-3-15
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

sugammadex; dexamethasone; neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative pain

  1, 6, 12, 24 hours postoperatively

• Postoperative nausea and vomiting

  1, 6, 12, 24 hours postoperatively

Other Outcomes (1)

• Time from end of surgery to extubation of patient

  minutes after administration of sugammadex (0 to 30 minutes)

Study Arms (2)

dexamethasone

ACTIVE COMPARATOR

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; Drug: sugammadex

normal saline

PLACEBO COMPARATOR

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; Drug: sugammadex

Interventions

Dexamethasone DRUG

active comparator

dexamethasone

Normal Saline DRUG

placebo controlled intervention

Also known as: N/S 0.9%

normal saline

sugammadex DRUG

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

dexamethasone; normal saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

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

Athens, 12462, Greece

Location

MeSH Terms

Interventions

Dexamethasone; Saline Solution; Sugammadex

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens, Greece

Study Record Dates

• First Submitted: May 16, 2015
• First Posted: July 29, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-07

Locations

GR (1)