Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

This study has been completed.
Information provided by:
Makerere University Identifier:
First received: December 7, 2009
Last updated: March 25, 2010
Last verified: March 2010

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).

Condition Intervention
Postoperative Nausea and Vomiting
Drug: dexamethasone
Other: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antiemetic Efficacy and Safety of Dexamethasone in Patients Undergoing Caesarean Sections at Mulago Hospital

Resource links provided by NLM:

Further study details as provided by Makerere University:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 250
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dexamethasone 8mg Drug: dexamethasone
single Bolus dose of dexamethasone 8mg
Placebo Comparator: normal saline Other: normal saline
2 ml 0.9% saline


Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01028547

Mulago National Refferal Hospital
Kampala, Uganda, 00256
Sponsors and Collaborators
Makerere University
Study Director: Tindimwebwa J V B, MD Makerere university dept of anesthesia
  More Information

No publications provided

Responsible Party: Dr Arthur Kwizera, Department of anaesthesia Makerere University College of health sciences Identifier: NCT01028547     History of Changes
Other Study ID Numbers: PONVDEX
Study First Received: December 7, 2009
Last Updated: March 25, 2010
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 15, 2014