Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Antiemetic Efficacy and Safety of Dexamethasone in Patients Undergoing Caesarean Sections at Mulago Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028547
• Other study ID #: PONVDEX
• Status: Completed
• Phase: N/A
• First received: December 7, 2009
• Last updated: March 25, 2010
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting

Intervention

Drug:
• dexamethasone
single Bolus dose of dexamethasone 8mg

Other:
• normal saline
2 ml 0.9% saline

Locations

Country	Name	City	State
Uganda	Mulago National Refferal Hospital	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of post nausea and or vomiting		24 hours	No
Secondary	perianal itching		24 hours	Yes
Secondary	hyperglycemia		24 hours	Yes
Secondary	hypertension		24 hours	Yes