Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: dexamethasone; Other: normal saline

• Registration Number: NCT01028547
• Lead Sponsor: Makerere University

Brief Summary

This is a randomised controlled double blinded clinical trial to determine the antiemetic efficacy and safety of either 8 mg of dexamethasone or normal saline (placebo) given 1 hour before induction of either spinal or general anaesthesia in 2 arms (of 150 each).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Study Start: 2010-01
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-25
• Last Update Posted: 2010-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• all woman above 18 years old presenting for obstetric surgery and have consented to study.

Exclusion Criteria

• refusal/unable to consent,
• younger than 18 years old,
• hypertensive,
• diabetic,
• preeclamptic,
• sepsis,
• ASAIIIE plus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexamethasone 8mg	dexamethasone	-
normal saline	normal saline	-

Primary Outcome Measures

Name	Time	Method
presence of post nausea and or vomiting	24 hours

Secondary Outcome Measures

Name	Time	Method
perianal itching	24 hours
hyperglycemia	24 hours
hypertension	24 hours

Trial Locations

Locations (1)

Mulago National Refferal Hospital; 🇺🇬 Kampala, Uganda