Dexamethasone for Postoperative Nausea and Vomiting - Full Text View

Sponsored by:	University of Jordan
Information provided by:	University of Jordan
ClinicalTrials.gov Identifier:	NCT00825071

Purpose

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.

Condition	Intervention	Phase
Postoperative Nausea and Vomiting	Drug: Dexamethasone Drug: Ondansetron Drug: normal saline	Phase IV

MedlinePlus related topics: Anesthesia Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Ondansetron hydrochloride Ondansetron Dexamethasone Sodium Phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Optimizing Anesthesia Antiemetic Measures Versus Combination With Dexamethasone or Ondansetron in the Prevention of Postoperative Nausea and Vomiting.

Further study details as provided by University of Jordan:

Primary Outcome Measures:

incidence of nausea and vomiting in each of the three studied groups. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the postoperative Visual Analog Score for pain assessment in each of the three studied groups [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Enrollment:	180
Study Start Date:	November 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group D: Active Comparator Dexamethasone group : This group received 8 mg dexamethasone	Drug: Dexamethasone 8 mg, Intravenous
Group O: Active Comparator Ondansetron Group: received 4 mg ondansetron	Drug: Ondansetron 4 mg, intravenously
Group P: Placebo Comparator (Group P) received normal saline (Placebo)	Drug: normal saline 2 ml, intravenously

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

.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825071

Locations

Jordan, -
Jordan University Hospital
Amman, -, Jordan, 11942

Sponsors and Collaborators

University of Jordan

Investigators

Principal Investigator:

Subhi M Al-Ghanem, MD, FFARCSI

University of Jordan

More Information

Publications:

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

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.

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.

Nesek-Adam V, Grizelj-Stojcić E, Rasić Z, Cala Z, Mrsić V, Smiljanić 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. Epub 2007 Feb 7.

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 Anesthesiol. 2006 Oct;18(6):1147-56.

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.

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):1277-89.

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.

Responsible Party:	University of Jordan ( Subhi M. Al-Ghanem, MD, FFARCSI )
Study ID Numbers:	UJordan
Study First Received:	January 15, 2009
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00825071 History of Changes
Health Authority:	Jordan: Ethical Committee

Keywords provided by University of Jordan:

Postoperative Nausea and Vomiting
Ondansetron
Dexamethasone

Study placed in the following topic categories:

Dexamethasone
Anti-Inflammatory Agents
Neurotransmitter Agents
Vomiting
Signs and Symptoms, Digestive
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Psychotropic Drugs
Antiemetics
Anesthetics
Hormones
Signs and Symptoms
Antipruritics

Nausea
Ondansetron
Dexamethasone acetate
Postoperative Nausea and Vomiting
Tranquilizing Agents
Antineoplastic Agents, Hormonal
Central Nervous System Depressants
Antipsychotic Agents
Glucocorticoids
Serotonin
Postoperative Complications
Anti-Anxiety Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Signs and Symptoms
Serotonin Antagonists
Pathologic Processes

Therapeutic Uses
Antipruritics
Nausea
Ondansetron
Dermatologic Agents
Dexamethasone acetate
Postoperative Nausea and Vomiting
Tranquilizing Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Glucocorticoids
Pharmacologic Actions
Serotonin Agents

ClinicalTrials.gov processed this record on May 07, 2009