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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-11

Study Completion Date

2018-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Cholecystectomy, Laparoscopic Anesthesia, General Reflex, Pupillary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pupillometry group

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

Group Type EXPERIMENTAL

Pupillometry guided anesthesia

Intervention Type 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.

SPI group

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

Group Type ACTIVE_COMPARATOR

SPI guided anesthesia

Intervention Type 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.

Control group

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

Group Type SHAM_COMPARATOR

Standard management

Intervention Type 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.

Interventions

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Pupillometry guided anesthesia

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.

Intervention Type PROCEDURE

SPI guided anesthesia

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.

Intervention Type PROCEDURE

Standard management

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.

Intervention Type PROCEDURE

Other Intervention Names

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PUPIL SPI Control

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No