Postoperative PainNCT06205355
Analgesia Nociception Index in Orthognathic Surgery
A study testing Analgesia/Nociception Index (ANI) monitoring and Standard monitoring in people with Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to determine whether goal-directed analgesia using ANI(Analgesia/Nociception Index) can improve the quality of postoperative recovery in patients undergoing maxillofacial surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Analgesia/Nociception Index (ANI) monitoring and Standard monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jan 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 or older undergoing maxillary, mandibular, or bimaxillary surgery under general anesthesia.
- adult patients who can provide written informed consent to participate in the study, understand the procedures of this study, and be able to complete patient-reported questionnaires adequately.
- adult patients who Have made an informed decision to participate in this study and have given written consent.
Who cannot join
- Patients with ASA physical status 4-5
- Emergency surgery
- Patients with chronic pain and related pain medications
- Patients with hypersensitivity to general anesthesia drugs and pain medications
- Patients with arrhythmia
- Pregnant women
- Others deemed unsuitable by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Children's Hospital
Seoul, 03080
Eun-Hee Kim, M.D., Ph.D., +82-2-2072-3664, beloveun@snu.ac.kr
About this study
Official title: Comparison of Goal-directed Analgesia Using ANI (Analgesia/Nociception Index) and Standard Analgesia During General Anesthesia in Patients Undergoing Orthognathic Surgery on Postoperative Quality of Recovery: a Prospective Randomized Controlled Trial
This study aims to determine whether goal-directed analgesia using ANI(Analgesia/Nociception Index) can improve the quality of postoperative recovery in patients undergoing maxillofacial surgery.
- Conditions
- Postoperative Pain
- Being tested
- Analgesia/Nociception Index (ANI) monitoring, Standard monitoring
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia/Nociception Index (ANI) monitoringDevice
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor.
Standard monitoringDevice
intraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision
| Study group | Role | What they receive |
|---|---|---|
| goal-directed analgesia using ANI monitoring | Experimental | Not described Receives: Device: Analgesia/Nociception Index (ANI) monitoring |
| Standard monitoring | Active comparator | Not described Receives: Device: Standard monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative QoR-15K score
Korean-translated QoR-15K (15-item Quality of Recovery (QoR-15) scale, minimum 0, maximum 150, higher scores mean a better outcome ) scores assessed by participants blinded to arm assignment 24 hours after surgery.
Measured: 24 hours after the end of surgery
Secondary outcomes (14)
Patient satisfaction
Postoperative satisfaction as assessed by study participants blinded to group assignment, recorded on an NRS scale from a low of 0 to a high of 10.
Measured: 24 hours after the end of surgery
intraoperative opioid consumption
total dose of remifentanil consumption during surgery
Measured: during surgery
intraoperative non-opioid consumption
total dose of non-opioid consumption during surgery
Measured: during surgery
intraoperative use of vasoactive drugs
total dose of vasoactive drugs during surgery
Measured: during surgery
The time-weighted average of the segments of the total anesthesia time where the ANI value did not remain above 50 and below 70.
Measured: during surgery
Percentage of time with a deviation of more than ±20% from the mean blood pressure measured on the ward as a percentage of total anesthesia time
Measured: during surgery
estimated blood loss
Measured: during surgery
total fluid administration during surgery
Measured: during surgery
extubation time
Measured: from the end of surgery to endotracheal tube extubation, up to 30 minutes
number of participants with postoperative nausea vomiting
Measured: 24 hours after the end of surgery
number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence)
Measured: 24 hours after the end of surgery
Total postoperative opioid consumption
Measured: 24 hours after the end of surgery
Total postoperative non-opioid consumption
Measured: 24 hours after the end of surgery
postoperative pain measured by numerical rating scale (NRS) scale (minimum 0, maximum 10, higher scores mean worse outcome)
Measured: 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start25 Jan 2024 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205355
- Sponsor's protocol ID
- H-2310-152-1481
- Status last verified
- Jan 2024
- First submitted
- 13 Dec 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Goal-directed Analgesia Using ANI (Analgesia/Nociception Index) and Standard Analgesia During General Anesthesia in Patients Undergoing Orthognathic Surgery on Postoperative Quality of Recovery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06205355
- Acronym / sponsor ID
- H-2310-152-1481
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Jan 2024 (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 aims to determine whether goal-directed analgesia using ANI(Analgesia/Nociception Index) can improve the quality of postoperative recovery in patients undergoing maxillofacial surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| goal-directed analgesia using ANI monitoring | Experimental | Device: Analgesia/Nociception Index (ANI) monitoring |
| Standard monitoring | Active comparator | Device: Standard monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients 18 or older undergoing maxillary, mandibular, or bimaxillary surgery under general anesthesia.
- adult patients who can provide written informed consent to participate in the study, understand the procedures of this study, and be able to complete patient-reported questionnaires adequately.
- adult patients who Have made an informed decision to participate in this study and have given written consent.
Key exclusion criteria (7 listed)
- Patients with ASA physical status 4-5
- Emergency surgery
- Patients with chronic pain and related pain medications
- Patients with hypersensitivity to general anesthesia drugs and pain medications
- Patients with arrhythmia
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 |
|---|---|---|
| Analgesia/Nociception Index (ANI) monitoringintraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to ANI monitor. | Device | goal-directed analgesia using ANI monitoring |
| Standard monitoringintraoperative analgesia was provided by infusion of remifentanil via target controlled infusion mode, which was controlled according to the clinician's decision | Device | Standard monitoring |
Primary outcome
Postoperative QoR-15K score
Time frame: 24 hours after the end of surgery
Korean-translated QoR-15K (15-item Quality of Recovery (QoR-15) scale, minimum 0, maximum 150, higher scores mean a better outcome ) scores assessed by participants blinded to arm assignment 24 hours after surgery.
14 secondary outcomes
Patient satisfaction
Time frame: 24 hours after the end of surgery
intraoperative opioid consumption
Time frame: during surgery
intraoperative non-opioid consumption
Time frame: during surgery
intraoperative use of vasoactive drugs
Time frame: during surgery
The time-weighted average of the segments of the total anesthesia time where the ANI value did not remain above 50 and below 70.
Time frame: during surgery
Percentage of time with a deviation of more than ±20% from the mean blood pressure measured on the ward as a percentage of total anesthesia time
Time frame: during surgery
estimated blood loss
Time frame: during surgery
total fluid administration during surgery
Time frame: during surgery
extubation time
Time frame: from the end of surgery to endotracheal tube extubation, up to 30 minutes
number of participants with postoperative nausea vomiting
Time frame: 24 hours after the end of surgery
number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence)
Time frame: 24 hours after the end of surgery
Total postoperative opioid consumption
Time frame: 24 hours after the end of surgery
Total postoperative non-opioid consumption
Time frame: 24 hours after the end of surgery
postoperative pain measured by numerical rating scale (NRS) scale (minimum 0, maximum 10, higher scores mean worse outcome)
Time frame: 24 hours after the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesia/Nociception Index (ANI) monitoring and Standard monitoring in people with Postoperative Pain, 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: looking for participants now, as of the sponsor's last update on 16 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative QoR-15K score (time frame: 24 hours after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2024.