- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03586791
Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia (PUPIL)
Comparison of Pupillometry-guided With Surgical Pleth Index (SPI) Guided General Anesthesia on Perioperative Opioid Consumption and Pain Intensity: a Pilot Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nam-gu
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Daegu, Nam-gu, Korea, Republic of, 42472
- Eugene Kim
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pupillometry group
In this group, anesthesia is performed using Pupillometry guided anesthesia.
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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.
Other Names:
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Active Comparator: SPI group
In this group, anesthesia is performed using SPI guided anesthesia.
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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.
Other Names:
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Sham Comparator: Control group
In this group, remifentanil concentration is controlled by the discretion of the anesthesiologist in charge of the patients (Standard management).
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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During the PACU stay (Within 1 hour after the PACU admission)
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Intraoperative opioid consumption
Time Frame: During the operation period (Within 2 hour after the anesthesia induction)
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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) |
During the operation period (Within 2 hour after the anesthesia induction)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative adverse events
Time Frame: Approximately within 1 hour after the PACU admission
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Check the postoperative nausea and vomiting, dizziness, desaturation, urinary retention, itching sensation and bradycardia
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Approximately within 1 hour after the PACU admission
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Pain score assessed by numeric rating scale (NRS) 1 day after the operation
Time Frame: On 1 day after the operation
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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.
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On 1 day after the operation
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Total analgesic consumption after PACU discharge
Time Frame: During 1 day after the operation
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Check the analgesic consumption after PACU discharge including oral, intramuscular and intravenous administration.
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During 1 day after the operation
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Intraoperative propofol consumption
Time Frame: During the operation period (Within 2 hour after the anesthesia induction)
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The amount of propofol consumption during the operation
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During the operation period (Within 2 hour after the anesthesia induction)
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PACU stay time
Time Frame: Approximately within 1 hour after the PACU admission
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Duration of time interval from PACU admission to discharge.
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Approximately within 1 hour after the PACU admission
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Intraoperative vasopressor or vasodilator consumption
Time Frame: During the operation period (Within 2 hour after the anesthesia induction)
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The amount of ephedrine and nicardipine consumption during the operation
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During the operation period (Within 2 hour after the anesthesia induction)
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Remnant sedation degree
Time Frame: Approximately within 1 hour after the PACU admission
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Remnant sedation is evaluated by Riker Sedation-Agitation Scale every 10 minutes after the PACU admission.
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Approximately within 1 hour after the PACU admission
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initial Pupillary unrest under ambient light (PUAL)
Time Frame: Just before the induction of anesthesia
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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.
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Just before the induction of anesthesia
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Pupillary unrest under ambient light (PUAL) on PACU arrival
Time Frame: Approximately within 1 min after the PACU admission
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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.
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Approximately within 1 min after the PACU admission
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative pupil change
Time Frame: Approximately 2 hour after the anesthesia induction
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Measure the pupillary diameter every 5 minutes after the tracheal intubation until the end of operation.
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Approximately 2 hour after the anesthesia induction
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Intraoperative SPI change
Time Frame: Approximately 2 hour after the anesthesia induction
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Check the SPI value throughout the operation using the vital recorder program.
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Approximately 2 hour after the anesthesia induction
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Intraoperative mean blood pressure change
Time Frame: Approximately 2 hour after the anesthesia induction
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Check the mean arterial blood pressure throughout the operation using the vital recorder program.
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Approximately 2 hour after the anesthesia induction
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Intraoperative heart rate change
Time Frame: Approximately 2 hour after the anesthesia induction
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Check the heart rate throughout the operation using the vital recorder program.
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Approximately 2 hour after the anesthesia induction
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Collaborators and Investigators
Publications and helpful links
General Publications
- Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCMC#5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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