Dexamethasone for Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Optimizing Anesthesia Antiemetic Measures Versus Combination With Dexamethasone or Ondansetron in the Prevention of Postoperative Nausea and Vomiting.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825071
• Other study ID #: UJordan
• Status: Completed
• Phase: Phase 4
• First received: January 15, 2009
• Last updated: May 12, 2016
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: May 2016
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The investigators want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy.

Description:

More than half of the patients undergoing laparoscopic cholecystectomy will have postoperative nausea and vomiting (PONV). PONV is related to surgical, anesthetic and patient factors.

We want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of PONV in patients undergoing laparoscopic cholecystectomy.

Three groups to be studied : (Group O) will receive 4 mg ondansetron, (Group D) will receive 8 mg dexamethasone and (Group P) will receive normal saline .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• (ASA) grade I and II, aged (18-70 years) who are scheduled for elective laparoscopic cholecystectomy under general anesthesia at the department of Anesthesia and Intensive Care, University of Jordan, Amman, Jordan between November 2007 and March 2008

Exclusion Criteria:

• All patients who received antiemetics or cortisone within 48 hr before surgery or those who required opioids before and after surgeries

• Pregnant, breast feeding ladies

• Any patient with BMI (Body Mass Index) > 34 kg/m²

• Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses or those with history of motion sickness were also excluded from the study protocol

Study Design

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Dexamethasone
8 mg, Intravenous
• Ondansetron
4 mg, intravenously
• normal saline
2 ml, intravenously

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

References & Publications (8)

Apfel CC, Kranke P, Katz MH, Goepfert C, Papenfuss T, Rauch S, Heineck R, Greim CA, Roewer N. Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design. Br J Anaesth. 200 — View Citation

Cechetto DF, Diab T, Gibson CJ, Gelb AW. The effects of propofol in the area postrema of rats. Anesth Analg. 2001 Apr;92(4):934-42. — View Citation

Chohedri AH, Matin M, Khosravi A. The impact of operative fluids on the prevention of postoperative anesthetic complications in ambulatory surgery--high dose vs low dose. Middle East J Anaesthesiol. 2006 Oct;18(6):1147-56. — View Citation

Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. — View Citation

Nesek-Adam V, Grizelj-Stojcic E, Rasic Z, Cala Z, Mrsic V, Smiljanic A. Comparison of dexamethasone, metoclopramide, and their combination in the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. Surg Endosc. 2007 Apr;21( — View Citation

Thune A, Appelgren L, Haglind E. Prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. A prospective randomized study of metoclopramide and transdermal hyoscine. Eur J Surg. 1995 Apr;161(4):265-8. — View Citation

Tramèr MR, Reynolds DJ, Moore RA, McQuay HJ. Efficacy, dose-response, and safety of ondansetron in prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized placebo-controlled trials. Anesthesiology. 1997 Dec;87(6):12 — View Citation

Watcha MF, White PF. Postoperative nausea and vomiting. Its etiology, treatment, and prevention. Anesthesiology. 1992 Jul;77(1):162-84. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of nausea and vomiting in each of the three studied groups.		5 months	Yes
Secondary	Assess the postoperative Visual Analog Score for pain assessment in each of the three studied groups		5 months	Yes