Cholecystectomy, LaparoscopicPUPIL_painNCT03794271
Effect of Pupilometer Guided Analgesia on Postoperative Pain
A study testing Pupilometer guided anesthesia and SPI guided anesthesia in people with Cholecystectomy, Laparoscopic and Anesthesia, General, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial summary
In this study, the investigators measure a pupil size every 5 minutes during the operation in patients undergoing laparoscopic cholecystectomy under general anesthesia. The investigators would compare the postoperative pain intensity between the group adjusted the anesthetic drug concentration based on the changes of… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Anesthesia, General, Reflex, Pupillary
- What is being tested?
- Pupilometer guided anesthesia and SPI guided anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2019to 10 May 2019
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 65 yr, American Society of Anesthesiologist Physical status(ASA PS) I to II, scheduled for a laparoscopic cholecystectomy under general anesthesia
Who cannot join
- Presence of ophthalmologic diseases such as Horner's syndrome or Sjogren's disease.
- Presence of neurologic or metabolic diseases
- Medicated that could interfere with the autonomous nervous system (e.g., b- blockers, anticholinergics)
- History of substance abuse or psychiatric disease with chronic pain or preoperative analgesics with pacemaker or arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pupilometer Guided Analgesia on Postoperative Pain Intensity and Perioperative Complications
In this study, the investigators measure a pupil size every 5 minutes during the operation in patients undergoing laparoscopic cholecystectomy under general anesthesia. The investigators would compare the postoperative pain intensity between the group adjusted the anesthetic drug concentration based on the changes of the pupil (Pupil group) and the group based on the changes of a surgical pleth index (SPI group).
- Being tested
- Pupilometer guided anesthesia, SPI guided anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupilometer guided anesthesiaProcedure or surgery
At least 10 min after anesthesia induction by target-controlled infusion of propofol and remifentanil, baseline values for pupillary diameter is recorded before any surgical procedure.
During the operation, propofol effect-site target concentration (Ce) is adjusted to maintain the bispectral index (BIS) value between 40 and 60. Remifentanil Ce is adapted every 5 min based on the changes of pupillary diameter. If the pupillary diameter is increased by more than 30% compared to baseline value, remifentanil concentration is increased by 0.5 ng/ml. If the pupillary diameter is maintained between 5 and 30 % change compared with baseline, remifentanil is not modified. In a case of pupillary diameter is decreased less than 5 % change of baseline, remifentanil concentration is decreased by 0.5 ng/ml.
SPI guided anesthesiaProcedure or surgery
During the operation, SPI value should be maintained between 20 and 50 by changing the infusion rate of remifentanil. Even if the SPI is maintained within the target range, the remifentanil infusion rate is increased by 0.5 ng/ml in a case of the SPI value suddenly arises by more than 10.
| Study group | Role | What they receive |
|---|---|---|
| Pupilometer group | Experimental | In this group, intraoperative analgesia is performed using pupilometer guided anesthesia. Receives: Procedure: Pupilometer guided anesthesia |
| SPI group | Active comparator | In this group, intraoperative analgesia is performed using SPI guided anesthesia Receives: Procedure: SPI guided anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)
Patients are asked to rate their pain according to the numeric rating scale (NRS, 0=no pain to 10= extreme pain imaginable) every 10 min after the PACU admission. Peak pain score is the peak NRS during PACU stay. Higher NRS represents a worse outcome.
Measured: During the PACU stay (Within 1 hour after the PACU admission)
Secondary outcomes (7)
Intraoperative remifentanil consumption rate
The amount of remifentanil consumption during the operation is calculated by following equation:
Total remifentanil consumption (mcg) / body weight of the patients (kg)/ duration of anesthesia (min)
Measured: During the operation period (Within 2 hour after the anesthesia induction)
Postoperative adverse events
Check the postoperative nausea and vomiting, dizziness, desaturation, urinary retention, itching sensation and bradycardia
Measured: Approximately within 1 hour after the PACU admission
Remnant sedation degree
Remnant sedation is evaluated by Riker Sedation-Agitation (RSA) Scale every 10 minutes after the PACU admission.
- unarousable, minimal or no response to noxious stimuli, does not communicate of follow commands
- very sedate, arouse to physical stimuli but does not communicate or follow command, may move spontaneously
- sedate, difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commands but drifts off again
- Calm and cooperative, calm and follows commands
- agitated, anxious or physically agitated and calms to verbal instructions
- very agitated, requiring restraint and frequent verbal reminding of limits, biting endotracheal tubes
- dangerous agitation, pulling at tracheal tube, trying to remove catheters or striking at staff
RSA scale 4 means normal. If the RSA <4, it means the patients are sedated. If the RSA >5, it means the patients are agitated.
Measured: Approximately within 1 hour after the PACU admission
Pain score assessed by numeric rating scale (NRS) 1 day after the operation
Patients are asked to rate their pain according to the numeric rating scale (NRS, 0=no pain to 10= extreme pain imaginable) 1 day after the operation. Higher NRS represents a worse outcome.
Measured: On 1 day after the operation
Total analgesic consumption after PACU discharge
Check the analgesic consumption after PACU discharge including oral, intramuscular and intravenous administration.
Measured: During 1 day after the operation
Intraoperative propofol consumption
The amount of propofol consumption during the operation
Measured: During the operation period (Within 2 hour after the anesthesia induction)
Intraoperative mean SPI
Check the SPI value throughout the operation using the vital recorder program.
Measured: Approximately during 2 hour after the anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start3 Jan 2019
- Primary completion9 May 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- 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, Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JongHae Kim, Daegu Catholic University Medical Center
- Investigators
- Eugene Kim, MD, PhD, Study chair, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794271
- Sponsor's protocol ID
- DCMC#6
- Acronym
- PUPIL_pain
- Status last verified
- Aug 2019
- First submitted
- 3 Jan 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.
PubMed 25988634Huybrechts I, Barvais L, Ducart A, Engelman E, Schmartz D, Koch M. Assessment of thoracic epidural analgesia during general anesthesia using pupillary reflex dilation: a preliminary study. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):664-7. doi: 10.1053/j.jvca.2006.04.004. Epub 2006 Aug 8.
PubMed 17023285Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.
PubMed 28719527Neice AE, Behrends M, Bokoch MP, Seligman KM, Conrad NM, Larson MD. Prediction of Opioid Analgesic Efficacy by Measurement of Pupillary Unrest. Anesth Analg. 2017 Mar;124(3):915-921. doi: 10.1213/ANE.0000000000001728.
PubMed 27941575Ledowski T, Burke J, Hruby J. Surgical pleth index: prediction of postoperative pain and influence of arousal. Br J Anaesth. 2016 Sep;117(3):371-4. doi: 10.1093/bja/aew226.
PubMed 27543532
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pupilometer Guided Analgesia on Postoperative Pain Intensity and Perioperative Complications
- ClinicalTrials.gov ID
- NCT03794271
- Acronym / sponsor ID
- PUPIL_pain / DCMC#6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 7 Jan 2019 (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.
In this study, the investigators measure a pupil size every 5 minutes during the operation in patients undergoing laparoscopic cholecystectomy under general anesthesia. The investigators would compare the postoperative pain intensity between the group adjusted the anesthetic drug concentration based on the changes of the pupil (Pupil group) and the group based on the changes of a surgical pleth index (SPI group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pupilometer group | Experimental | Procedure: Pupilometer guided anesthesiaIn this group, intraoperative analgesia is performed using pupilometer guided anesthesia. |
| SPI group | Active comparator | Procedure: SPI guided anesthesiaIn this group, intraoperative analgesia is performed using SPI guided anesthesia |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 20 to 65 yr, American Society of Anesthesiologist Physical status(ASA PS) I to II, scheduled for a laparoscopic cholecystectomy under general anesthesia
Key exclusion criteria (4 listed)
- Presence of ophthalmologic diseases such as Horner's syndrome or Sjogren's disease.
- Presence of neurologic or metabolic diseases
- Medicated that could interfere with the autonomous nervous system (e.g., b- blockers, anticholinergics)
- History of substance abuse or psychiatric disease with chronic pain or preoperative analgesics with pacemaker or 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 |
|---|---|---|
| Pupilometer guided anesthesiaAt least 10 min after anesthesia induction by target-controlled infusion of propofol and remifentanil, baseline values for pupillary diameter is recorded before any surgical procedure. During the operation, propofol effect-site target concentration (Ce) is adjusted to maintain the bispectral index (BIS) value between 40 and 60. Remifentanil Ce is adapted every 5 min based on the changes of pupillary diameter. If the pupillary diameter is increased by more than 30% compared to baseline value, remifentanil concentration is increased by 0.5 ng/ml. If the pupillary diameter is maintained between 5 and 30 % change compared with baseline, remifentanil is not modified. In a case of pupillary diameter is decreased less than 5 % change of baseline, remifentanil concentration is decreased by 0.5 ng/ml. | Procedure or surgery | Pupilometer group |
| SPI guided anesthesiaDuring the operation, SPI value should be maintained between 20 and 50 by changing the infusion rate of remifentanil. Even if the SPI is maintained within the target range, the remifentanil infusion rate is increased by 0.5 ng/ml in a case of the SPI value suddenly arises by more than 10. | Procedure or surgery | SPI group |
Primary outcome
Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)
Time frame: During the PACU stay (Within 1 hour after the PACU admission)
Patients are asked to rate their pain according to the numeric rating scale (NRS, 0=no pain to 10= extreme pain imaginable) every 10 min after the PACU admission. Peak pain score is the peak NRS during PACU stay. Higher NRS represents a worse outcome.
7 secondary outcomes
Intraoperative remifentanil consumption rate
Time frame: During the operation period (Within 2 hour after the anesthesia induction)
Postoperative adverse events
Time frame: Approximately within 1 hour after the PACU admission
Remnant sedation degree
Time frame: Approximately within 1 hour after the PACU admission
Pain score assessed by numeric rating scale (NRS) 1 day after the operation
Time frame: On 1 day after the operation
Total analgesic consumption after PACU discharge
Time frame: During 1 day after the operation
Intraoperative propofol consumption
Time frame: During the operation period (Within 2 hour after the anesthesia induction)
Intraoperative mean SPI
Time frame: Approximately during 2 hour after the anesthesia induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Background: PubMed 25988634Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.
- Background: PubMed 17023285Huybrechts I, Barvais L, Ducart A, Engelman E, Schmartz D, Koch M. Assessment of thoracic epidural analgesia during general anesthesia using pupillary reflex dilation: a preliminary study. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):664-7. doi: 10.1053/j.jvca.2006.04.004. Epub 2006 Aug 8.
- Background: PubMed 28719527Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.
- Background: PubMed 27941575Neice AE, Behrends M, Bokoch MP, Seligman KM, Conrad NM, Larson MD. Prediction of Opioid Analgesic Efficacy by Measurement of Pupillary Unrest. Anesth Analg. 2017 Mar;124(3):915-921. doi: 10.1213/ANE.0000000000001728.
- Background: PubMed 27543532Ledowski T, Burke J, Hruby J. Surgical pleth index: prediction of postoperative pain and influence of arousal. Br J Anaesth. 2016 Sep;117(3):371-4. doi: 10.1093/bja/aew226.
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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.
Eugene Kim, MD, PhD study chair
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pupilometer guided anesthesia and SPI guided anesthesia in people with Cholecystectomy, Laparoscopic and Anesthesia, General, run by Daegu Catholic University Medical Center 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 12 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU) (time frame: During the PACU stay (Within 1 hour after the PACU admission)). 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 NCT03794271, which also lists 5 linked publications.
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 12 Aug 2019; AzTrials last refreshed its copy on 2 Nov 2026.