The Effect of PCA on PONV After Microvascular Decompression

Study Overview
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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.

Official Title
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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

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: NSAID
* Drug: Opioid


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSAID group<br>NSAID based patient-controlled analgesia will connected to intravenous line for pain control. | Drug: NSAID<br>* NSAID based patient-controlled analgesia will connected to intravenous line for pain control.<br>|
| Active Comparator: Opioid group<br>Opioid based patient-controlled analgesia will connected to intravenous line for pain control. | Drug: Opioid<br>* Opioid based patient-controlled analgesia will connected to intravenous line for pain control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting | Incidence | postoperative 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting | Severity accessed using numeric rating scale (0=none, 10=worst PONV possible) | Postoperative 30 minutes, 1 hours, 24 hours, 48 hours | 
| Postoperative pain | pain intensity will be assessed using numeric rating scale (0=none, 10=worst pain possible) | 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 | 
| Satisfaction score for postoperative nausea and vomiting | using 11-point scale (0=Worst dissatisfied, 10=Very satisfied) | postoperative 48 hours | 
| Satisfaction score for postoperative pain | using 11-point scale (0=Worst dissatisfied, 10=Very satisfied) | postoperative 48 hours |