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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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • perianal itching [ Time Frame: 24 hours ]
  • hyperglycemia [ Time Frame: 24 hours ]
  • hypertension [ Time Frame: 24 hours ]

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   (Adult)
Sexes 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.
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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

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

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
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal 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 24, 2017