Effect of Dexamethasone on the Action of Sugammadex

NCT ID: NCT02510157

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

active comparator

sugammadex

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

placebo controlled intervention

sugammadex

Intervention Type DRUG

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

Interventions

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Dexamethasone

active comparator

Intervention Type DRUG

Normal Saline

placebo controlled intervention

Intervention Type DRUG

sugammadex

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

Intervention Type DRUG

Other Intervention Names

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N/S 0.9%

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chrysanthi Batistaki

Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens, Greece

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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711/19-3-15

Identifier Type: -

Identifier Source: org_study_id

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