Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

— Loop-NVPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876290
• Other study ID #: 2012/14
• Secondary ID: 2012-001486-32
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2013
• Last updated: October 28, 2016
• Start date: May 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Dexamethasone and Ondansetron
Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting
• Placebo
Placebo

Locations

Country	Name	City	State
France	Clinique de la Baie des Citrons	Nouméa

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative nausea or vomiting	Severe nausea (> to 4 on a 0-10 visual analogue scale) or vomiting	24 hours	No
Secondary	incidence of nausea	incidence of nausea with delay of occurrence and severity (0-10 visual analogue scale)	one day after anesthesia	No
Secondary	incidence of vomiting	incidence of vomiting with delay of occurrence	one day after anesthesia	No
Secondary	rescue treatment	use of rescue treatment for PONV	one day after anesthesia	No
Secondary	pain	postoperative pain score (0-10 visual analogue scale)	one day after anesthesia	No
Secondary	sedation	postoperative sedation (0-10 visual analogue scale)	one day after surgery	No