Clinical trial NCT04466046: The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients
Official title: The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female patients aged 20 to 65 with ASA physical status 1 or 2 undergoing laparoscopic cholecystectomy

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: percentage of patients receiving ramosetron or palonosetron in each groups
timeFrame: 48 hours after surgery
measure: severity of postoperative nausea in PONV group
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: postoperative pain
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
state: Nam-gu
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Jung A Lim, MD
role: STUDY_CHAIR
References: