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Completed

NCT Number: NCT01028547

Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

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).

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mulago National Refferal Hospital

Kampala, 00256, Uganda

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

single Bolus dose of dexamethasone 8mg

Normal Saline

Other

2 ml 0.9% saline

Primary outcomes

  1. presence of post nausea and or vomiting

    Time frame: 24 hours

Secondary outcomes

  1. perianal itching

    Time frame: 24 hours

  2. hyperglycemia

    Time frame: 24 hours

  3. hypertension

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2009
Registry last updated
Mar 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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