Postoperative Nausea and VomitingNCT05189704
The Effect of PCA on PONV After Microvascular Decompression
A study testing NSAID and Opioid in people with Postoperative Nausea and Vomiting, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- NSAID and Opioid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo elective microvascular decompression surgery
- American Society of Anesthesiologists grade 1 or 2
- 19 - 65 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Chang-Hoon Koo, vollock9@gmail.com
About this study
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
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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- NSAID, Opioid
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDDrug
NSAID based patient-controlled analgesia will connected to intravenous line for pain control.
OpioidDrug
Opioid based patient-controlled analgesia will connected to intravenous line for pain control.
| Study group | Role | What they receive |
|---|---|---|
| NSAID group | Experimental | NSAID based patient-controlled analgesia will connected to intravenous line for pain control. Receives: Drug: NSAID |
| Opioid group | Active comparator | Opioid based patient-controlled analgesia will connected to intravenous line for pain control. Receives: Drug: Opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting
Incidence
Measured: postoperative 48 hours
Secondary outcomes (7)
Postoperative nausea and vomiting
Severity accessed using numeric rating scale (0=none, 10=worst PONV possible)
Measured: 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)
Measured: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Postoperative PCA consumption
Measured: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Rescue antiemetics requirement
Measured: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Rescue analgesic requirement
Measured: 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)
Measured: postoperative 48 hours
Satisfaction score for postoperative pain
using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start20 Dec 2021
- Primary completion15 Feb 2023
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hoon Koo, Seoul National University Bundang Hospital
- Investigators
- Chang-Hoon Koo, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189704
- Sponsor's protocol ID
- MVD-PCA
- Status last verified
- Apr 2023
- First submitted
- 7 Dec 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koo CH, Ji SY, Han JH, Kim J, Bae YK, Jeon YT, Ryu JH. Effect of patient-controlled analgesia on development of postoperative nausea and vomiting in patients undergoing microvascular decompression: a prospective randomized controlled trial. J Neurosurg. 2024 Feb 9;141(1):260-267. doi: 10.3171/2023.12.JNS231817. Print 2024 Jul 1.
PubMed 38335521
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05189704
- Acronym / sponsor ID
- MVD-PCA
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAID group | Experimental | Drug: NSAIDNSAID based patient-controlled analgesia will connected to intravenous line for pain control. |
| Opioid group | Active comparator | Drug: OpioidOpioid based patient-controlled analgesia will connected to intravenous line for pain control. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who undergo elective microvascular decompression surgery
- American Society of Anesthesiologists grade 1 or 2
- 19 - 65 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSAIDNSAID based patient-controlled analgesia will connected to intravenous line for pain control. | Drug | NSAID group |
| OpioidOpioid based patient-controlled analgesia will connected to intravenous line for pain control. | Drug | Opioid group |
Primary outcome
Postoperative nausea and vomiting
Time frame: postoperative 48 hours
Incidence
7 secondary outcomes
Postoperative nausea and vomiting
Time frame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Postoperative pain
Time frame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Postoperative PCA consumption
Time frame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Rescue antiemetics requirement
Time frame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Rescue analgesic requirement
Time frame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Satisfaction score for postoperative nausea and vomiting
Time frame: postoperative 48 hours
Satisfaction score for postoperative pain
Time frame: postoperative 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 38335521Koo CH, Ji SY, Han JH, Kim J, Bae YK, Jeon YT, Ryu JH. Effect of patient-controlled analgesia on development of postoperative nausea and vomiting in patients undergoing microvascular decompression: a prospective randomized controlled trial. J Neurosurg. 2024 Feb 9;141(1):260-267. doi: 10.3171/2023.12.JNS231817. Print 2024 Jul 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Hoon Koo principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSAID and Opioid in people with Postoperative Nausea and Vomiting, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Hoon Koo (+821085098841, vollock9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomiting (time frame: postoperative 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05189704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.