Clinical trial NCT03586791: Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia
Official title: Comparison of Pupillometry-guided With Surgical Pleth Index (SPI) Guided General Anesthesia on Perioperative Opioid Consumption and Pain Intensity: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystectomy, Laparoscopic
Anesthesia, General
Reflex, Pupillary
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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 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).


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

Primary outcomes:
measure: Intraoperative opioid consumption
timeFrame: During the operation period (Within 2 hour after the anesthesia induction)
measure: Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)
timeFrame: During the PACU stay (Within 1 hour after the PACU admission)
Secondary outcomes:
measure: Intraoperative propofol consumption
timeFrame: During the operation period (Within 2 hour after the anesthesia induction)
measure: Intraoperative vasopressor or vasodilator consumption
timeFrame: During the operation period (Within 2 hour after the anesthesia induction)
measure: PACU stay time
timeFrame: Approximately within 1 hour after the PACU admission
measure: Postoperative adverse events
timeFrame: Approximately within 1 hour after the PACU admission
measure: Remnant sedation degree
timeFrame: Approximately within 1 hour after the PACU admission
measure: Total analgesic consumption after PACU discharge
timeFrame: During 1 day after the operation
measure: Pain score assessed by numeric rating scale (NRS) 1 day after the operation
timeFrame: On 1 day after the operation
measure: initial Pupillary unrest under ambient light (PUAL)
timeFrame: Just before the induction of anesthesia
measure: Pupillary unrest under ambient light (PUAL) on PACU arrival
timeFrame: Approximately within 1 min after the PACU admission
Other outcomes:
measure: Intraoperative pupil change
timeFrame: Approximately 2 hour after the anesthesia induction
measure: Intraoperative SPI change
timeFrame: Approximately 2 hour after the anesthesia induction
measure: Intraoperative mean blood pressure change
timeFrame: Approximately 2 hour after the anesthesia induction
measure: Intraoperative heart rate change
timeFrame: Approximately 2 hour after the anesthesia induction
Locations:
city: Daegu
country: Korea, Republic of
facility: Eugene Kim
state: Nam-gu
Study officials:
affiliation: Assistant professor
name: Eugene Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.
citation: Huybrechts I, Barvais L, Ducart A, Engelman E, Schmartz D, Koch M. Assessment of thoracic epidural analgesia during general anesthesia using pupillary reflex dilation: a preliminary study. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):664-7. doi: 10.1053/j.jvca.2006.04.004. Epub 2006 Aug 8.
citation: Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.
citation: Neice AE, Behrends M, Bokoch MP, Seligman KM, Conrad NM, Larson MD. Prediction of Opioid Analgesic Efficacy by Measurement of Pupillary Unrest. Anesth Analg. 2017 Mar;124(3):915-921. doi: 10.1213/ANE.0000000000001728.
citation: Ledowski T, Burke J, Hruby J. Surgical pleth index: prediction of postoperative pain and influence of arousal. Br J Anaesth. 2016 Sep;117(3):371-4. doi: 10.1093/bja/aew226.
citation: Kim JH, Jwa EK, Choung Y, Yeon HJ, Kim SY, Kim E. Comparison of Pupillometry With Surgical Pleth Index Monitoring on Perioperative Opioid Consumption and Nociception During Propofol-Remifentanil Anesthesia: A Prospective Randomized Controlled Trial. Anesth Analg. 2020 Nov;131(5):1589-1598. doi: 10.1213/ANE.0000000000004958.