The Effect of PCA on PONV After Microvascular Decompression
Primary Purpose
Postoperative Nausea and Vomiting
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NSAID
Opioid
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NSAID group
Opioid group
Arm Description
NSAID based patient-controlled analgesia will connected to intravenous line for pain control.
Opioid based patient-controlled analgesia will connected to intravenous line for pain control.
Outcomes
Primary Outcome Measures
Postoperative nausea and vomiting
Incidence
Secondary Outcome Measures
Postoperative nausea and vomiting
Severity accessed using numeric rating scale (0=none, 10=worst PONV possible)
Postoperative pain
pain intensity will be assessed using numeric rating scale (0=none, 10=worst pain possible)
Postoperative PCA consumption
Rescue antiemetics requirement
Rescue analgesic requirement
Satisfaction score for postoperative nausea and vomiting
using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)
Satisfaction score for postoperative pain
using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)
Full Information
NCT ID
NCT05189704
First Posted
December 7, 2021
Last Updated
April 12, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05189704
Brief Title
The Effect of PCA on PONV After Microvascular Decompression
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NSAID group
Arm Type
Experimental
Arm Description
NSAID based patient-controlled analgesia will connected to intravenous line for pain control.
Arm Title
Opioid group
Arm Type
Active Comparator
Arm Description
Opioid based patient-controlled analgesia will connected to intravenous line for pain control.
Intervention Type
Drug
Intervention Name(s)
NSAID
Intervention Description
NSAID based patient-controlled analgesia will connected to intravenous line for pain control.
Intervention Type
Drug
Intervention Name(s)
Opioid
Intervention Description
Opioid based patient-controlled analgesia will connected to intravenous line for pain control.
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Description
Incidence
Time Frame
postoperative 48 hours
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Description
Severity accessed using numeric rating scale (0=none, 10=worst PONV possible)
Time Frame
Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Title
Postoperative pain
Description
pain intensity will be assessed using numeric rating scale (0=none, 10=worst pain possible)
Time Frame
Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Title
Postoperative PCA consumption
Time Frame
Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Title
Rescue antiemetics requirement
Time Frame
Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Title
Rescue analgesic requirement
Time Frame
Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Title
Satisfaction score for postoperative nausea and vomiting
Description
using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)
Time Frame
postoperative 48 hours
Title
Satisfaction score for postoperative pain
Description
using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)
Time Frame
postoperative 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang-Hoon Koo
Phone
+821085098841
Email
vollock9@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Hoon Koo
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Hoon Koo
Email
vollock9@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of PCA on PONV After Microvascular Decompression
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