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

Daegu Catholic University Medical Center

Status: Completed

Conditions: Postoperative Nausea and Vomiting

Study type: Observational

Funder types: Other

Identifiers

NCT04466046

19-100

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 68 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

68 participants in 2 patient groups

PONV group

Description:

Patients with PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg

no PONV group

Description:

Patients with no PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg