Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Placebo; Drug: Dexamethasone and Ondansetron

• Registration Number: NCT01876290
• Lead Sponsor: Hopital Foch

Brief Summary

The investigators want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.

Detailed Description

Obese patients having bariatric surgery have frequently postoperative nausea and vomiting (PONV). We want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.

Two groups to be studied: one will receive 4 mg dexamethasone at the end of the anesthetic induction and 4 mg ondansetron at the end of the surgical procedure, one will receive normal saline.

One hundred twenty consecutive patients meeting the inclusion and exclusion criteria and who give written informed consent to participate in the study will be randomly assigned to one of two experimental groups using a 1:1 ratio.

Patients will be continuously monitored in the post anesthesia care unit (PACU) and the medical floor for a total of 24 hours post operatively. Episodes of nausea, vomiting and administration of rescue therapy for either nausea or vomiting will be recorded and time stamped. In addition, severity of nausea will be evaluated by the patient using a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Rescue therapy for PONV episodes will consist of 4 mg ondansetron followed by 0.625 mg droperidol if necessary.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-06-09
• Study First Posted: 2013-06-12
• Primary Completion: 2014-01
• Study Completion: 2015-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Adult patients aged 18-75 years
• Scheduled for bariatric surgery under total intra-venous closed-loop anesthesia
• Apfel score equal or greater than 2
• Consenting to participate in the study

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Exclusion Criteria

• Pregnant, breast feeding women
• Allergy
• Contraindication to dexamethasone
• Contraindication to ondansetron
• Contraindication to propofol, remifentanil, morphine, ketoprofen
• Limit to the use of bispectral index

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Each patient will receive placebo instead of Dexamethasone and Ondansetron
Dexamethasone and Ondansetron	Dexamethasone and Ondansetron	Each patient will receive Dexamethasone and Ondansetron

Primary Outcome Measures

Name	Time	Method
Postoperative nausea or vomiting	24 hours	Severe nausea (\> to 4 on a 0-10 visual analogue scale) or vomiting

Secondary Outcome Measures

Name	Time	Method
incidence of nausea	one day after anesthesia	incidence of nausea with delay of occurrence and severity (0-10 visual analogue scale)
incidence of vomiting	one day after anesthesia	incidence of vomiting with delay of occurrence
rescue treatment	one day after anesthesia	use of rescue treatment for PONV
pain	one day after anesthesia	postoperative pain score (0-10 visual analogue scale)
sedation	one day after surgery	postoperative sedation (0-10 visual analogue scale)

Trial Locations

Locations (1)

Clinique de la Baie des Citrons; 🇫🇷 Nouméa, France