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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05189704

Enrollment

Registered

2022-01-12

Start date

2021-12-20

Completion date

2023-08-31

Last updated

2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

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.

Interventions

DRUGNSAID

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

DRUGOpioid

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative nausea and vomiting	postoperative 48 hours	Incidence

Secondary

Measure	Time frame	Description
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)
Postoperative PCA consumption	Postoperative 30 minutes, 1 hours, 24 hours, 48 hours	—
Rescue antiemetics requirement	Postoperative 30 minutes, 1 hours, 24 hours, 48 hours	—
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)
Satisfaction score for postoperative nausea and vomiting	postoperative 48 hours	using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)
Satisfaction score for postoperative pain	postoperative 48 hours	using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)
Rescue analgesic requirement	Postoperative 30 minutes, 1 hours, 24 hours, 48 hours	—

Countries

South Korea

Contacts

Primary ContactChang-Hoon Koo

vollock9@gmail.com+821085098841

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026