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Completed

NCT Number: NCT00825071

Dexamethasone for Postoperative Nausea and Vomiting

The investigators want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy.

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jordan University Hospital

Amman, 11942, Jordan

About this study

More than half of the patients undergoing laparoscopic cholecystectomy will have postoperative nausea and vomiting (PONV). PONV is related to surgical, anesthetic and patient factors.

We want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of PONV in patients undergoing laparoscopic cholecystectomy.

Three groups to be studied : (Group O) will receive 4 mg ondansetron, (Group D) will receive 8 mg dexamethasone and (Group P) will receive normal saline .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (ASA) grade I and II, aged (18-70 years) who are scheduled for elective laparoscopic cholecystectomy under general anesthesia at the department of Anesthesia and Intensive Care, University of Jordan, Amman, Jordan between November 2007 and March 2008

Exclusion criteria

  • All patients who received antiemetics or cortisone within 48 hr before surgery or those who required opioids before and after surgeries
  • Pregnant, breast feeding ladies
  • Any patient with BMI (Body Mass Index) > 34 kg/m²
  • Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses or those with history of motion sickness were also excluded from the study protocol

Treatment and study plan

Dexamethasone

Drug

8 mg, Intravenous

ondansetron

Drug

4 mg, intravenously

normal saline

Drug

2 ml, intravenously

Primary outcomes

  1. incidence of nausea and vomiting in each of the three studied groups.

    Time frame: 5 months

Secondary outcomes

  1. Assess the postoperative Visual Analog Score for pain assessment in each of the three studied groups

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

Optimizing Anesthesia Antiemetic Measures Versus Combination With Dexamethasone or Ondansetron in the Prevention of Postoperative Nausea and Vomiting.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 19, 2009
Registry last updated
May 13, 2016

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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