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Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

M

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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