Dexamethasone for Postoperative Nausea and Vomiting

University of Jordan

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: normal saline; Drug: Ondansetron; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00825071

UJordan

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 180 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

Group D

Active Comparator group

Description:

Dexamethasone group : This group received 8 mg dexamethasone

Treatment:

Drug: Dexamethasone

Group O

Active Comparator group

Description:

Ondansetron Group: received 4 mg ondansetron

Treatment:

Drug: Ondansetron

Group P

Placebo Comparator group

Description:

(Group P) received normal saline (Placebo)

Treatment:

Drug: normal saline