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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
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