Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting (Loop-NVPO)

Should we Associate Dexamethasone and Ondansetron to Closed-loop Anesthesia to Reduce the Incidence of Postoperative Nausea and Vomiting After Bariatric Surgery?

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Placebo; Drug: Dexamethasone and Ondansetron

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nouméa, France, 98800
    • Clinique de la Baie des Citrons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone and Ondansetron; Each patient will receive Dexamethasone and Ondansetron	Drug: Dexamethasone and Ondansetron; Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting
Placebo Comparator: Placebo; Each patient will receive placebo instead of Dexamethasone and Ondansetron	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea or vomiting	Severe nausea (> to 4 on a 0-10 visual analogue scale) or vomiting	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hopital Foch

Publications and helpful links

General Publications

• Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
• Song JW, Park EY, Lee JG, Park YS, Kang BC, Shim YH. The effect of combining dexamethasone with ondansetron for nausea and vomiting associated with fentanyl-based intravenous patient-controlled analgesia. Anaesthesia. 2011 Apr;66(4):263-7. doi: 10.1111/j.1365-2044.2011.06648.x.
• Bataille A, Letourneulx JF, Charmeau A, Lemedioni P, Leger P, Chazot T, Le Guen M, Diemunsch P, Fischler M, Liu N. Impact of a prophylactic combination of dexamethasone-ondansetron on postoperative nausea and vomiting in obese adult patients undergoing laparoscopic sleeve gastrectomy during closed-loop propofol-remifentanil anaesthesia: A randomised double-blind placebo-controlled study. Eur J Anaesthesiol. 2016 Dec;33(12):898-905. doi: 10.1097/EJA.0000000000000427.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: June 9, 2013
• First Posted (Estimate): June 12, 2013

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Complications; Anesthesiology; Closed-loop
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Dexamethasone; Ondansetron
• Other Study ID Numbers: 2012/14; 2012-001486-32 (EudraCT Number)