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Completed

NCT Number: NCT03933605

Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

In the present study, midazolam and palonosetron in combination were more effective than palonosetron alone in lowering the incidence and severity of postoperative nausea and vomiting in the initial 2 h after laparoscopic cholecystectomy. Postoperative clinical complications were not different in both groups.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eun kyung Choi

Daegu, Korea (the Republic Of), 41944, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patients (aged 20 to 65 years) scheduled for laparoscopic cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification of 1 or 2

Exclusion criteria

  • The patients with a history of allergy to any other drugs used in this study, gastrointestinal disorder, previous PONV, pregnant woman, breastfeeding woman, use of antiemetics within 24 hours or body mass index > 30 kg/m2

Treatment and study plan

midazolam and palonosetron group

Drug

intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting

palonosetron group

Drug

intravenous palonosetron administraion as prevention of postoperative nausea and vomiting

Primary outcomes

  1. incidence of postoperative nausea and vomiting

    Time frame: 24 hours after surgery

    0=none; 1=occur

  2. severity of postoperative nausea and vomiting

    Time frame: 24 hours after surgery

    0 = absent; 1 = mild; 2 = moderate; 3 = severe

Sponsors and collaborators

Lead sponsor

Yeungnam University College of Medicine

Other

Registry information

Official study title

Comparison of Palonosetron With Combined Palonosetron and Midazolam for Preventing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 1, 2019
Registry last updated
May 1, 2019

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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