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

NCT03586791 | Completed

• 1 other identifier: DCMC#5
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 concentration based on the changes of the pupil (Pupil group) and the group based on the changes of a surgical pleth index (SPI group).

Conditions

Cholecystectomy, Laparoscopic; Anesthesia, General; Reflex, Pupillary

Outcome Measures

Primary Outcomes (2)

• 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)

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

• 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.

  During the PACU stay (Within 1 hour after the PACU admission)

Secondary Outcomes (9)

• Intraoperative propofol consumption

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

• Intraoperative vasopressor or vasodilator consumption

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

• PACU stay time

  Approximately within 1 hour after the PACU admission

• Postoperative adverse events

  Approximately within 1 hour after the PACU admission

• Remnant sedation degree

  Approximately within 1 hour after the PACU admission

Other Outcomes (4)

• Intraoperative pupil change

  Approximately 2 hour after the anesthesia induction

• Intraoperative SPI change

  Approximately 2 hour after the anesthesia induction

• Intraoperative mean blood pressure change

  Approximately 2 hour after the anesthesia induction

Study Arms (3)

Pupillometry group

EXPERIMENTAL

In this group, anesthesia is performed using Pupillometry guided anesthesia.

Procedure: Pupillometry guided anesthesia

SPI group

ACTIVE COMPARATOR

In this group, anesthesia is performed using SPI guided anesthesia.

Procedure: SPI guided anesthesia

Control group

SHAM COMPARATOR

In this group, remifentanil concentration is controlled by the discretion of the anesthesiologist in charge of the patients (Standard management).

Procedure: Standard management

Interventions

Pupillometry guided anesthesia PROCEDURE

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.

Also known as: PUPIL

Pupillometry group

SPI guided anesthesia PROCEDURE

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.

Also known as: SPI

SPI group

Standard management PROCEDURE

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.

Also known as: Control

Control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Sites (1)

Eugene Kim

Daegu, Nam-gu, 42472, South Korea

Location

Related Publications (6)

• Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.

  PMID: 25988634 BACKGROUND

• 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.

  PMID: 17023285 BACKGROUND

• 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.

  PMID: 28719527 BACKGROUND

• 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.

  PMID: 27941575 BACKGROUND

• 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.

  PMID: 27543532 BACKGROUND

• 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.

  PMID: 33079883 DERIVED

Study Officials

• Eugene Kim, MD, PhD

  Assistant professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 30, 2018
• First Posted: July 16, 2018
• Study Start: July 11, 2018
• Primary Completion: November 29, 2018
• Study Completion: November 30, 2018
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

KR (1)