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Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01028547
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : March 26, 2010
Sponsor:
Information provided by:
Makerere University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: dexamethasone Other: normal saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : January 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: dexamethasone 8mg Drug: dexamethasone
single Bolus dose of dexamethasone 8mg
Placebo Comparator: normal saline Other: normal saline
2 ml 0.9% saline


Outcome Measures
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Primary Outcome Measures :
  1. presence of post nausea and or vomiting [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. perianal itching [ Time Frame: 24 hours ]
  2. hyperglycemia [ Time Frame: 24 hours ]
  3. hypertension [ Time Frame: 24 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028547


Locations
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Uganda
Mulago National Refferal Hospital
Kampala, Uganda, 00256
Sponsors and Collaborators
Makerere University
Investigators
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Study Director: Tindimwebwa J V B, MD Makerere university dept of anesthesia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Arthur Kwizera, Department of anaesthesia Makerere University College of health sciences
ClinicalTrials.gov Identifier: NCT01028547    
Other Study ID Numbers: PONVDEX
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: March 26, 2010
Last Verified: March 2010
Keywords provided by Makerere University:
PONV
Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents