NCT03794271

Effect of Pupilometer Guided Analgesia on Postoperative Pain

Effect of Pupilometer Guided Analgesia on Postoperative Pain Intensity and Perioperative Complications

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Daegu Catholic University Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Cholecystectomy, Laparoscopic
• Anesthesia, General
• Reflex, Pupillary

Interventions

Type	Name	Description
PROCEDURE	Pupilometer 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.
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.

Timeline

• Start date: 2019-01-03
• Primary completion: 2019-05-09
• Completion: 2019-05-10
• First posted: 2019-01-07
• Last updated: 2019-08-12

Locations

1 site across 1 country: South Korea