Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05189704
  4. Details
NCT05189704 Clinical Trial

The Effect of PCA on PONV After Microvascular Decompression

Postoperative Nausea and Vomiting Clinical Trial

Official title:
The Effect of Patient-controlled Analgesia (Ketorolac vs. Fentanyl) on the Development of Postoperative Nausea and Vomiting in Patients Undergoing Microvascular Decompression: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05189704
Other study ID # MVD-PCA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 20, 2021
Est. completion date August 31, 2023

Study information
Verified date April 2023
Source Seoul National University Hospital
Contact Chang-Hoon Koo
Phone +821085098841
Email vollock9@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized, controlled, double-blinded, and parallel design study. A total 94 patients will be randomized to receive ketorolac or fentanyl based patient-controlled analgesia after microvascular decompression surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 94
Est. completion date August 31, 2023
Est. primary completion date February 15, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria: - Patients who undergo elective microvascular decompression surgery - American Society of Anesthesiologists grade 1 or 2 - 19 - 65 years old Exclusion Criteria: - Refuse to participate to the study - Refuse to use Patient-controlled analgesia - Body Mass Index < 18.5 kg/m2 or > 35 kg/m2 - history of craniotomy or chemotheraphy - Patients who used preoperative antiemetics within 24h before surgery - Severe renal or hepatic dysfunction - Pregnant

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NSAID
NSAID based patient-controlled analgesia will connected to intravenous line for pain control.
• Opioid
Opioid based patient-controlled analgesia will connected to intravenous line for pain control.

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative nausea and vomiting Incidence postoperative 48 hours
Secondary Postoperative nausea and vomiting Severity accessed using numeric rating scale (0=none, 10=worst PONV possible) Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Secondary Postoperative pain pain intensity will be assessed using numeric rating scale (0=none, 10=worst pain possible) Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Secondary Postoperative PCA consumption Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Secondary Rescue antiemetics requirement Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Secondary Rescue analgesic requirement Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Secondary Satisfaction score for postoperative nausea and vomiting using 11-point scale (0=Worst dissatisfied, 10=Very satisfied) postoperative 48 hours
Secondary Satisfaction score for postoperative pain using 11-point scale (0=Worst dissatisfied, 10=Very satisfied) postoperative 48 hours
See also
  Status Clinical Trial Phase
Completed NCT04466046 - The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients
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 NCT02550795 - Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer N/A
Completed NCT02449291 - Study of APD421 as PONV Treatment (no Prior Prophylaxis) Phase 3
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