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Clinical Trials/NCT03794271
NCT03794271
Completed
Not Applicable

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

Daegu Catholic University Medical Center1 site in 1 country84 target enrollmentJanuary 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cholecystectomy, Laparoscopic
Sponsor
Daegu Catholic University Medical Center
Enrollment
84
Locations
1
Primary Endpoint
Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)
Status
Completed
Last Updated
6 years ago

Overview

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 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).

Registry
clinicaltrials.gov
Start Date
January 3, 2019
End Date
May 10, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Daegu Catholic University Medical Center
Responsible Party
Principal Investigator
Principal Investigator

JongHae Kim

Associate professor

Daegu Catholic University Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)

Time Frame: During the PACU stay (Within 1 hour after the PACU admission)

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.

Secondary Outcomes

  • Intraoperative mean SPI(Approximately during 2 hour after the anesthesia induction)
  • Total analgesic consumption after PACU discharge(During 1 day after the operation)
  • Intraoperative propofol consumption(During the operation period (Within 2 hour after the anesthesia induction))
  • Intraoperative remifentanil consumption rate(During the operation period (Within 2 hour after the anesthesia induction))
  • Postoperative adverse events(Approximately within 1 hour after the PACU admission)
  • Remnant sedation degree(Approximately within 1 hour after the PACU admission)
  • Pain score assessed by numeric rating scale (NRS) 1 day after the operation(On 1 day after the operation)

Study Sites (1)

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