NCT01028547

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 26, 2010

Status Verified

March 1, 2010

Enrollment Period

2 months

First QC Date

December 7, 2009

Last Update Submit

March 25, 2010

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV

Outcome Measures

Primary Outcomes (1)

  • presence of post nausea and or vomiting

    24 hours

Secondary Outcomes (3)

  • perianal itching

    24 hours

  • hyperglycemia

    24 hours

  • hypertension

    24 hours

Study Arms (2)

dexamethasone 8mg

ACTIVE COMPARATOR
Drug: dexamethasone

normal saline

PLACEBO COMPARATOR
Other: normal saline

Interventions

dexamethasoneDRUG

single Bolus dose of dexamethasone 8mg

dexamethasone 8mg
normal salineOTHER

2 ml 0.9% saline

normal saline

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • all woman above 18 years old presenting for obstetric surgery and have consented to study.

You may not qualify if:

  • refusal/unable to consent,
  • younger than 18 years old,
  • hypertensive,
  • diabetic,
  • preeclamptic,
  • sepsis,
  • ASAIIIE plus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago National Refferal Hospital

Kampala, 00256, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 34002866DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

DexamethasoneSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Tindimwebwa J V B, MD

    Makerere university dept of anesthesia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

January 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 26, 2010

Record last verified: 2010-03

Locations

UG(1)