Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

March 25, 2010 updated by: Makerere University

Antiemetic Efficacy and Safety of Dexamethasone in Patients Undergoing Caesarean Sections at Mulago Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda, 00256
        • Mulago National Refferal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: normal saline
Other: normal saline
2 ml 0.9% saline
Active Comparator: dexamethasone 8mg
Drug: dexamethasone
single Bolus dose of dexamethasone 8mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence of post nausea and or vomiting
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
perianal itching
Time Frame: 24 hours
24 hours
hyperglycemia
Time Frame: 24 hours
24 hours
hypertension
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Investigators

  • Study Director: Tindimwebwa J V B, MD, Makerere university dept of anesthesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

March 26, 2010

Last Update Submitted That Met QC Criteria

March 25, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PONVDEX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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