The Effect of PCA on PONV After Microvascular Decompression

NCT ID: NCT05189704

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-20

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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NSAID group

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

Group Type EXPERIMENTAL

NSAID

Intervention Type DRUG

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

Opioid group

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

Group Type ACTIVE_COMPARATOR

Opioid

Intervention Type DRUG

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

Interventions

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NSAID

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

Intervention Type DRUG

Opioid

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang-Hoon Koo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang-Hoon Koo

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chang-Hoon Koo

Role: CONTACT

+821085098841

Facility Contacts

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Chang-Hoon Koo

Role: primary

Other Identifiers

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MVD-PCA

Identifier Type: -

Identifier Source: org_study_id

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