Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04466046
Other study ID # 19-100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 4, 2019
Est. completion date June 30, 2020

Study information

Verified date October 2022
Source Daegu Catholic University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Daegu Catholic University Medical Center Daegu Nam-gu

Sponsors (1)

Lead Sponsor Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of patients receiving ramosetron or palonosetron in each groups percentage of patients receiving ramosetron or palonosetron 48 hours after surgery
Primary severity of postoperative nausea in PONV group 0 = none, 1 = mild, 2 = moderate, 3 = severe 48 hours after surgery
Secondary postoperative pain numerical analog scale : 0 to 10 48 hours after surgery
See also
  Status Clinical Trial Phase
Completed NCT03139383 - Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery N/A
Recruiting NCT04069806 - Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section N/A
Completed NCT04043247 - Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting N/A
Terminated NCT01975727 - Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting Phase 2
Completed NCT03662672 - Rib Raising for Post-operative Ileus N/A
Completed NCT00090155 - 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED) Phase 3
Recruiting NCT05375721 - Prevention of PONV With Traditional Chinese Medicine N/A
Completed NCT02480088 - Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism Phase 4
Recruiting NCT06137027 - Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting Early Phase 1
Not yet recruiting NCT05529004 - A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy Phase 2
Completed NCT02944942 - Risk Factors for Postoperative Nausea/Vomiting N/A
Recruiting NCT02571153 - Low Doses of Ketamine and Postoperative Quality of Recovery Phase 4
Completed NCT02449291 - Study of APD421 as PONV Treatment (no Prior Prophylaxis) Phase 3
Completed NCT02550795 - Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer N/A
Recruiting NCT01442012 - Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery N/A
Completed NCT01478165 - Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting N/A
Unknown status NCT01268748 - Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain N/A
Completed NCT02143531 - Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting Phase 4
Completed NCT00734929 - Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy Phase 4
Withdrawn NCT00151099 - Safety of Preoperative Oral Administration of a High Caloric Drink With Protein Phase 4