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Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
dexamethasone
normal saline
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring PONV

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Mulago National Refferal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

dexamethasone 8mg

normal saline

Arm Description

Outcomes

Primary Outcome Measures

presence of post nausea and or vomiting

Secondary Outcome Measures

perianal itching
hyperglycemia
hypertension

Full Information

First Posted
December 7, 2009
Last Updated
March 25, 2010
Sponsor
Makerere University
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1. Study Identification

Unique Protocol Identification Number
NCT01028547
Brief Title
Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients
Official Title
Antiemetic Efficacy and Safety of Dexamethasone in Patients Undergoing Caesarean Sections at Mulago Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Makerere University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexamethasone 8mg
Arm Type
Active Comparator
Arm Title
normal saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
single Bolus dose of dexamethasone 8mg
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
2 ml 0.9% saline
Primary Outcome Measure Information:
Title
presence of post nausea and or vomiting
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
perianal itching
Time Frame
24 hours
Title
hyperglycemia
Time Frame
24 hours
Title
hypertension
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tindimwebwa J V B, MD
Organizational Affiliation
Makerere university dept of anesthesia
Official's Role
Study Director
Facility Information:
Facility Name
Mulago National Refferal Hospital
City
Kampala
ZIP/Postal Code
00256
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
34002866
Citation
Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.
Results Reference
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Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

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