Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 7, 2009
March 25, 2010
January 2010
March 2010   (final data collection date for primary outcome measure)
presence of post nausea and or vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028547 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients
Antiemetic Efficacy and Safety of Dexamethasone in Patients Undergoing Caesarean Sections at Mulago Hospital

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Postoperative Nausea and Vomiting
  • Drug: dexamethasone
    single Bolus dose of dexamethasone 8mg
  • Other: normal saline
    2 ml 0.9% saline
  • Active Comparator: dexamethasone 8mg
    Intervention: Drug: dexamethasone
  • Placebo Comparator: normal saline
    Intervention: Other: normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01028547
PONVDEX
Yes
Dr Arthur Kwizera, Department of anaesthesia Makerere University College of health sciences
Makerere University
Not Provided
Study Director: Tindimwebwa J V B, MD Makerere university dept of anesthesia
Makerere University
March 2010

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