The Effect of PCA on PONV After Microvascular Decompression
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
1 other identifier
interventional
94
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2021
CompletedStudy Start
First participant enrolled
December 20, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedApril 13, 2023
April 1, 2023
1.2 years
December 7, 2021
April 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative nausea and vomiting
Incidence
postoperative 48 hours
Secondary Outcomes (7)
Postoperative nausea and vomiting
Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Postoperative pain
Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Postoperative PCA consumption
Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Rescue antiemetics requirement
Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Rescue analgesic requirement
Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
- +2 more secondary outcomes
Study Arms (2)
NSAID group
EXPERIMENTALNSAID based patient-controlled analgesia will connected to intravenous line for pain control.
Opioid group
ACTIVE COMPARATOROpioid based patient-controlled analgesia will connected to intravenous line for pain control.
Interventions
Eligibility Criteria
You may qualify if:
- Patients who undergo elective microvascular decompression surgery
- American Society of Anesthesiologists grade 1 or 2
- years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chang-Hoon Koo
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
December 7, 2021
First Posted
January 12, 2022
Study Start
December 20, 2021
Primary Completion
February 15, 2023
Study Completion
August 31, 2023
Last Updated
April 13, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share