Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

Makerere University

Status: Completed

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: dexamethasone; Other: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01028547

PONVDEX

Details and patient eligibility

About

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).

Enrollment: 250 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

250 participants in 2 patient groups, including a placebo group

dexamethasone 8mg

Active Comparator group

Treatment:

Drug: dexamethasone

normal saline

Placebo Comparator group

Treatment:

Other: normal saline