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Dexamethasone for Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
Jordan
Study Type
Interventional
Intervention
Dexamethasone
Ondansetron
normal saline
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting, Ondansetron, Dexamethasone

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jordan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group D

Group O

Group P

Arm Description

Dexamethasone group : This group received 8 mg dexamethasone

Ondansetron Group: received 4 mg ondansetron

(Group P) received normal saline (Placebo)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2009
Last Updated
May 12, 2016
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT00825071
Brief Title
Dexamethasone for Postoperative Nausea and Vomiting
Official Title
Optimizing Anesthesia Antiemetic Measures Versus Combination With Dexamethasone or Ondansetron in the Prevention of Postoperative Nausea and Vomiting.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Postoperative Nausea and Vomiting, Ondansetron, Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Dexamethasone group : This group received 8 mg dexamethasone
Arm Title
Group O
Arm Type
Active Comparator
Arm Description
Ondansetron Group: received 4 mg ondansetron
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
(Group P) received normal saline (Placebo)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
8 mg, Intravenous
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
4 mg, intravenously
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
2 ml, intravenously
Primary Outcome Measure Information:
Title
incidence of nausea and vomiting in each of the three studied groups.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Assess the postoperative Visual Analog Score for pain assessment in each of the three studied groups
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhi M Al-Ghanem, MD, FFARCSI
Organizational Affiliation
University of Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University Hospital
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

Citations:
PubMed Identifier
10475299
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. doi: 10.1097/00000539-199909000-00022.
Results Reference
background
PubMed Identifier
1609990
Citation
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.
Results Reference
result
PubMed Identifier
7612769
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.
Results Reference
result
PubMed Identifier
12067003
Citation
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.
Results Reference
result
PubMed Identifier
17285386
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(4):607-12. doi: 10.1007/s00464-006-9122-7. Epub 2007 Feb 7.
Results Reference
result
PubMed Identifier
17263269
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.
Results Reference
result
PubMed Identifier
11273930
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. doi: 10.1097/00000539-200104000-00027.
Results Reference
result
PubMed Identifier
9416710
Citation
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.
Results Reference
result

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Dexamethasone for Postoperative Nausea and Vomiting

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