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The Effect of PCA on PONV After Microvascular Decompression

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05189704
Collaborator
(none)
94
Enrollment
1
Location
2
Arms
12.4
Anticipated Duration (Months)
7.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Dec 20, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: NSAID group

NSAID based patient-controlled analgesia will connected to intravenous line for pain control.

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

Opioid based patient-controlled analgesia will connected to intravenous line for pain control.

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

Outcome Measures

Primary Outcome Measures

  1. Postoperative nausea and vomiting [postoperative 48 hours]

    Incidence

Secondary Outcome Measures

  1. Postoperative nausea and vomiting [Postoperative 30 minutes, 1 hours, 24 hours, 48 hours]

    Severity accessed using numeric rating scale (0=none, 10=worst PONV possible)

  2. Postoperative pain [Postoperative 30 minutes, 1 hours, 24 hours, 48 hours]

    pain intensity will be assessed using numeric rating scale (0=none, 10=worst pain possible)

  3. Postoperative PCA consumption [Postoperative 30 minutes, 1 hours, 24 hours, 48 hours]

  4. Rescue antiemetics requirement [Postoperative 30 minutes, 1 hours, 24 hours, 48 hours]

  5. Rescue analgesic requirement [Postoperative 30 minutes, 1 hours, 24 hours, 48 hours]

  6. Satisfaction score for postoperative nausea and vomiting [postoperative 48 hours]

    using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)

  7. Satisfaction score for postoperative pain [postoperative 48 hours]

    using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Chang-Hoon Koo, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang-Hoon Koo, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT05189704
Other Study ID Numbers:
  • MVD-PCA
First Posted:
Jan 12, 2022
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Analgesics, Opioid

Study Results

No Results Posted as of Jan 13, 2022