Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

This study has been completed.

Sponsor:

Information provided by:

Makerere University

ClinicalTrials.gov Identifier:

NCT01028547

First received: December 7, 2009

Last updated: March 25, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2009

Last Updated Date

March 25, 2010

Start Date ^ICMJE

January 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

presence of post nausea and or vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01028547 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

perianal itching [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
hyperglycemia [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
hypertension [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Postoperative Nausea and Vomiting

Intervention ^ICMJE

Drug: dexamethasone
single Bolus dose of dexamethasone 8mg
Other: normal saline
2 ml 0.9% saline

Study Arm (s)

Active Comparator: dexamethasone 8mg
Intervention: Drug: dexamethasone
Placebo Comparator: normal saline
Intervention: Other: normal saline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

250

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Uganda

Administrative Information

NCT Number ^ICMJE

NCT01028547

Other Study ID Numbers ^ICMJE

PONVDEX

Has Data Monitoring Committee

Yes

Responsible Party

Dr Arthur Kwizera, Department of anaesthesia Makerere University College of health sciences

Study Sponsor ^ICMJE

Makerere University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Tindimwebwa J V B, MD

Makerere university dept of anesthesia

Information Provided By

Makerere University

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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