Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

NCT ID: NCT01028547

Last Updated: 2010-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexamethasone 8mg

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

single Bolus dose of dexamethasone 8mg

normal saline

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

2 ml 0.9% saline

Interventions

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dexamethasone

single Bolus dose of dexamethasone 8mg

Intervention Type DRUG

normal saline

2 ml 0.9% saline

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Makerere University

OTHER

Sponsor Role lead

Responsible Party

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Department of anaesthesia Makerere University College of health sciences

Principal Investigators

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Tindimwebwa J V B, MD

Role: STUDY_DIRECTOR

Makerere university dept of anesthesia

Locations

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Mulago National Refferal Hospital

Kampala, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type DERIVED
PMID: 34002866 (View on PubMed)

Other Identifiers

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PONVDEX

Identifier Type: -

Identifier Source: org_study_id

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