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NCT Number: NCT04466046

The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients

Nausea and vomiting after surgery are one of the complications that occur after general anesthesia, and the frequency is reported to range from 10% to 80% in the high-risk group. Several studies have introduced drugs and methods to prevent nausea and vomiting after surgery. Among them, midazolam administered before surgery is known to have anti-anxiolytic and sedative effects on the prevention of nausea and vomiting after surgery. It has also been reported to increase its effectiveness when administered with other antiemetic agents.

The purpose of this study is to compare the effects of administration of combination with midazolam and different antiemetic agents on the prevention of postoperative nausea and vomiting in high-risk patients.

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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

20 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Daegu Catholic University Medical Center

Daegu, Nam-gu, 42472, South Korea

About this study

This prospective study evaluates female, nonsmoking patients undergoing laparoscopic cholecystectomy. The patients are divided into those with and without postoperative nausea and vomiting. The purpose of this study is to compare and observe the effect of administration of midazolam and two different antiemetics on prevention of postoperative nausea and vomiting.

0.05mg/kg of midazolam is administered intravenously 10 minutes before surgery as a pretreatment. 0.3mg ramosetron is administered intravenously right before the end of surgery and 0.075mg palonosetron is administered intravenously immediately after induction of anesthesia. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain severity was evaluated at 2 hours, 24hours, and 48 hours after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20-65 years old with American Society of Anesthesiologists (ASA) physical status 1-2 and scheduled for laparoscopic cholecystectomy.

Exclusion criteria

  • pregnant or breast feeding patients
  • smokers
  • patients with history of chronic opioid abuse
  • hypersensitivity to 5-HT3 receptor antagonists or analgesics
  • those who were antiemetic or opioid treatment within 24 hours prior to surgery

Treatment and study plan

Primary outcomes

  1. percentage of patients receiving ramosetron or palonosetron in each groups

    Time frame: 48 hours after surgery

    percentage of patients receiving ramosetron or palonosetron

  2. severity of postoperative nausea in PONV group

    Time frame: 48 hours after surgery

    0 = none, 1 = mild, 2 = moderate, 3 = severe

Secondary outcomes

  1. postoperative pain

    Time frame: 48 hours after surgery

    numerical analog scale : 0 to 10

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2020
Registry last updated
Nov 2, 2022

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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