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The Effect of PCA on PONV After Microvascular Decompression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05189704
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Chang-Hoon Koo, Seoul National University Bundang Hospital

Study Description
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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
Postoperative Nausea and Vomiting Drug: NSAID Drug: Opioid Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 20, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: postoperative 48 hours ]
    Incidence


Secondary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours ]
    Severity accessed using numeric rating scale (0=none, 10=worst PONV possible)

  2. Postoperative pain [ Time Frame: 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 [ Time Frame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours ]
  4. Rescue antiemetics requirement [ Time Frame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours ]
  5. Rescue analgesic requirement [ Time Frame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours ]
  6. Satisfaction score for postoperative nausea and vomiting [ Time Frame: postoperative 48 hours ]
    using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)

  7. Satisfaction score for postoperative pain [ Time Frame: postoperative 48 hours ]
    using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05189704


Contacts
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Contact: Chang-Hoon Koo +821085098841 vollock9@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Chang-Hoon Koo       vollock9@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Chang-Hoon Koo Seoul National University Bundang Hospital
More Information
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Responsible Party: Chang-Hoon Koo, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT05189704    
Other Study ID Numbers: MVD-PCA
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents