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Effect of Pupilometer Guided Analgesia on Postoperative Pain (PUPIL_pain)

D

Daegu Catholic University Medical Center

Status

Completed

Conditions

Reflex, Pupillary
Anesthesia, General
Cholecystectomy, Laparoscopic

Treatments

Procedure: Pupilometer guided anesthesia
Procedure: SPI guided anesthesia

Study type

Interventional

Funder types

Other

Identifiers

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 postoperative pain intensity 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

84 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

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

84 participants in 2 patient groups

Pupilometer group
Experimental group
Description:
In this group, intraoperative analgesia is performed using pupilometer guided anesthesia.
Treatment:
Procedure: Pupilometer guided anesthesia
SPI group
Active Comparator group
Description:
In this group, intraoperative analgesia is performed using SPI guided anesthesia
Treatment:
Procedure: SPI guided anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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