Dexamethasone for Postoperative Nausea and Vomiting

NCT00825071 | Completed Phase 4 DMC

• 1 other identifier: UJordan
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and Vomiting; Ondansetron; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• incidence of nausea and vomiting in each of the three studied groups.

  5 months

Secondary Outcomes (1)

• Assess the postoperative Visual Analog Score for pain assessment in each of the three studied groups

  5 months

Study Arms (3)

Group D

ACTIVE COMPARATOR

Dexamethasone group : This group received 8 mg dexamethasone

Drug: Dexamethasone

Group O

ACTIVE COMPARATOR

Ondansetron Group: received 4 mg ondansetron

Drug: Ondansetron

Group P

PLACEBO COMPARATOR

(Group P) received normal saline (Placebo)

Drug: normal saline

Interventions

Dexamethasone DRUG

8 mg, Intravenous

Group D

Ondansetron DRUG

4 mg, intravenously

Group O

normal saline DRUG

2 ml, intravenously

Group P

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, 11942, Jordan

Location

Related Publications (8)

• 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. doi: 10.1097/00000539-199909000-00022.

  PMID: 10475299 BACKGROUND

• Watcha MF, White PF. Postoperative nausea and vomiting. Its etiology, treatment, and prevention. Anesthesiology. 1992 Jul;77(1):162-84. doi: 10.1097/00000542-199207000-00023.

  PMID: 1609990 RESULT

• 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.

  PMID: 7612769 RESULT

• 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. 2002 May;88(5):659-68. doi: 10.1093/bja/88.5.659.

  PMID: 12067003 RESULT

• 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(4):607-12. doi: 10.1007/s00464-006-9122-7. Epub 2007 Feb 7.

  PMID: 17285386 RESULT

• 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.

  PMID: 17263269 RESULT

• 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. doi: 10.1097/00000539-200104000-00027.

  PMID: 11273930 RESULT

• Tramer 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):1277-89. doi: 10.1097/00000542-199712000-00004.

  PMID: 9416710 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Ondansetron; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Subhi M Al-Ghanem, MD, FFARCSI

  University of Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 19, 2009
• Study Start: November 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

JO (1)