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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
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028547

Locations
Uganda
Mulago National Refferal Hospital
Kampala, Uganda, 00256
Sponsors and Collaborators
Makerere University
Investigators
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
ClinicalTrials.gov 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:
PONV

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Antiemetics
Dexamethasone
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013