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Cholecystectomy, LaparoscopicPUPILNCT03586791

Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia

A study testing Pupillometry guided anesthesia, SPI guided anesthesia and Standard management in people with Cholecystectomy, Laparoscopic and Anesthesia, General, run by Daegu Catholic University Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 intraoperative opioid consumption and postoperative pain between the group adjusted the anesthetic drug… Read more about this study

Who is it for?
Ages 20 to 65 years
What is being tested?
Pupillometry guided anesthesia, SPI guided anesthesia and Standard management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteSouth Korea
Study dates
11 Jul 2018to 30 Nov 2018
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.

South Korea1 site

  • Eugene Kim

    Daegu, Nam-gu, 42472

Other trials in South Korea

About this study

Official title: Comparison of Pupillometry-guided With Surgical Pleth Index (SPI) Guided General Anesthesia on Perioperative Opioid Consumption and Pain Intensity: a Pilot Study

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 intraoperative opioid consumption and postoperative pain 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
Pupillometry guided anesthesia, SPI guided anesthesia, Standard management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pupillometry guided anesthesiaProcedure or surgery

    Also called PUPIL

    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

    Also called SPI

    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.

  • Standard managementProcedure or surgery

    Also called Control

    During the operation, propofol effect-site target concentration (Ce) is adjusted to maintain the bispectral index (BIS) value between 40 and 60.

    Remifentanil concentration is controlled by the discretion of the anesthesiologist in charge of the patients.

Study groups in NCT03586791
Study groupRoleWhat they receive
Pupillometry groupExperimentalIn this group, anesthesia is performed using Pupillometry guided anesthesia.
Receives: Procedure: Pupillometry guided anesthesia
SPI groupActive comparatorIn this group, anesthesia is performed using SPI guided anesthesia.
Receives: Procedure: SPI guided anesthesia
Control groupSham comparatorIn this group, remifentanil concentration is controlled by the discretion of the anesthesiologist in charge of the patients (Standard management).
Receives: Procedure: Standard management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative opioid consumption

    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)

  2. 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 (9)

  1. Intraoperative propofol consumption

    The amount of propofol consumption during the operation

    Measured: During the operation period (Within 2 hour after the anesthesia induction)

  2. Intraoperative vasopressor or vasodilator consumption

    The amount of ephedrine and nicardipine consumption during the operation

    Measured: During the operation period (Within 2 hour after the anesthesia induction)

  3. PACU stay time

    Duration of time interval from PACU admission to discharge.

    Measured: Approximately within 1 hour after the PACU admission

  4. 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

  5. Remnant sedation degree

    Remnant sedation is evaluated by Riker Sedation-Agitation Scale every 10 minutes after the PACU admission.

    1. unarousable, minimal or no response to noxious stimuli, does not communicate of follow commands
    2. very sedate, arouse to physical stimuli but does not communicate or follow command, may move spontaneously
    3. sedate, difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commands but drifts off again
    4. Calm and cooperative, calm and follows commands
    5. agitated, anxious or physically agitated and calms to verbal instructions
    6. very agitated, requiring restraint and frequent verbal reminding of limits, biting endotracheal tubes
    7. dangerous agitation, pulling at tracheal tube, trying to remove catheters or striking at staff

    Measured: Approximately within 1 hour after the PACU admission

  6. 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

  7. 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

  8. initial Pupillary unrest under ambient light (PUAL)

    At room light, the pupil is taken for 8 seconds at a frame rate of 30 frames per second. The pupillometer generates raw data in the format of pupil diameter versus time. We define the PUAL as the area under the curve of power spectral density between 0.23 and 3 Hz. The integral of the area is calculated using the composite Simpson's rule.

    Measured: Just before the induction of anesthesia

  9. Pupillary unrest under ambient light (PUAL) on PACU arrival

    At room light, the pupil is taken for 8 seconds at a frame rate of 30 frames per second. The pupillometer generates raw data in the format of pupil diameter versus time. We define the PUAL as the area under the curve of power spectral density between 0.23 and 3 Hz. The integral of the area is calculated using the composite Simpson's rule.

    Measured: Approximately within 1 min after the PACU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2018
  2. Study start11 Jul 2018
  3. Primary completion29 Nov 2018
  4. Study completion30 Nov 2018

Resources

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
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03586791
Sponsor's protocol ID
DCMC#5
Acronym
PUPIL
Status last verified
Oct 2019
First submitted
30 Jun 2018
Last updated
25 Oct 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 25988634

  • Huybrechts 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 17023285

  • Sabourdin 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 28719527

  • Neice 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 27941575

  • Ledowski 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

  • Kim JH, Jwa EK, Choung Y, Yeon HJ, Kim SY, Kim E. Comparison of Pupillometry With Surgical Pleth Index Monitoring on Perioperative Opioid Consumption and Nociception During Propofol-Remifentanil Anesthesia: A Prospective Randomized Controlled Trial. Anesth Analg. 2020 Nov;131(5):1589-1598. doi: 10.1213/ANE.0000000000004958.

    PubMed 33079883

Questions about this trial

What is this clinical trial studying?

A study testing Pupillometry guided anesthesia, SPI guided anesthesia and Standard management 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 6 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 25 Oct 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. Some participants in this study may receive a placebo. 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?

Intraoperative opioid consumption (time frame: During the operation period (Within 2 hour after the anesthesia induction)). The study lists 2 primary outcomes in all. 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 NCT03586791, which also lists 6 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 25 Oct 2019.

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