Effect of Dexamethasone on the Action of Sugammadex

October 2, 2016 updated by: Chrysanthi Batistaki, Attikon Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 12462
        • 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Dexamethasone
active comparator
Drug: sugammadex
sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery
Placebo Comparator: 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.
Drug: sugammadex
sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery
Drug: Normal Saline
placebo controlled intervention
Other Names:
  • N/S 0.9%

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from end of surgery to extubation of patient
Time Frame: 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)
minutes after administration of sugammadex (0 to 30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 16, 2015

First Submitted That Met QC Criteria

July 26, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 2, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 711/19-3-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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