Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia (PUPIL)

Daegu Catholic University Medical Center

Status: Completed

Conditions: Reflex, Pupillary; Anesthesia, General; Cholecystectomy, Laparoscopic

Treatments: Procedure: Pupillometry guided anesthesia; Procedure: SPI guided anesthesia; Procedure: Standard management

Study type: Interventional

Funder types: Other

Identifiers

NCT03586791

DCMC#5

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 3 patient groups

Pupillometry group

Experimental group

Description:

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

Treatment:

Procedure: Pupillometry guided anesthesia

SPI group

Active Comparator group

Description:

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

Treatment:

Procedure: SPI guided anesthesia

Control group

Sham Comparator group

Description:

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

Treatment:

Procedure: Standard management