Antiemetic Efficacy and Safety of Dexamethasone in Obstet... | NCT01028547

Studies
Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

NCT01028547

Sponsor

Makerere University

Status

Completed

Last Update Posted

Mar 26, 2010Estimated

Enrollment

250Actual

Phase

Not Applicable

Conditions

Postoperative Nausea and Vomiting

Interventions

dexamethasone
normal saline

Countries

Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Dec 7, 2009

First Submission Date that Met QC Criteria

Dec 8, 2009

First Posted Date

Dec 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2010

Last Update Posted Date

Mar 26, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dexamethasone 8mg	Active Comparator		Drug: dexamethasone
normal saline	Placebo Comparator		Other: normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dexamethasone	Drug	single Bolus dose of dexamethasone 8mg	dexamethasone 8mg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
perianal itching		24 hours
hyperglycemia		24 hours
hypertension

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tindimwebwa J V B, MD	Makerere university dept of anesthesia	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mulago National Refferal Hospital		Kampala		00256	Uganda

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34002866	Derived	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.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

ID	Term
D003907	Dexamethasone
D000077330	Saline Solution

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids