Effect of Pupilometer Guided Analgesia on Postoperative Pain (PUPIL_pain)

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

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).

Study Overview

• Status: Completed
• Conditions: Anesthesia, General; Cholecystectomy, Laparoscopic; Reflex, Pupillary
• Intervention / Treatment: Procedure: Pupilometer guided anesthesia; Procedure: SPI guided anesthesia

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Nam-gu
    • Daegu, Nam-gu, Korea, Republic of, 42472
      • Eugene Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pupilometer group; In this group, intraoperative analgesia is performed using pupilometer guided anesthesia.	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.
Active Comparator: SPI group; In this group, intraoperative analgesia is performed using SPI guided anesthesia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)	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.	During the PACU stay (Within 1 hour after the PACU admission)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative remifentanil consumption rate	The amount of remifentanil consumption during the operation is calculated by following equation: Total remifentanil consumption (mcg) / body weight of the patients (kg)/ duration of anesthesia (min)	During the operation period (Within 2 hour after the anesthesia induction)
Postoperative adverse events	Check the postoperative nausea and vomiting, dizziness, desaturation, urinary retention, itching sensation and bradycardia	Approximately within 1 hour after the PACU admission
Remnant sedation degree	Remnant sedation is evaluated by Riker Sedation-Agitation (RSA) Scale every 10 minutes after the PACU admission.; unarousable, minimal or no response to noxious stimuli, does not communicate of follow commands; very sedate, arouse to physical stimuli but does not communicate or follow command, may move spontaneously; sedate, difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commands but drifts off again; Calm and cooperative, calm and follows commands; agitated, anxious or physically agitated and calms to verbal instructions; very agitated, requiring restraint and frequent verbal reminding of limits, biting endotracheal tubes; dangerous agitation, pulling at tracheal tube, trying to remove catheters or striking at staff RSA scale 4 means normal. If the RSA <4, it means the patients are sedated. If the RSA >5, it means the patients are agitated.	Approximately within 1 hour after the PACU admission
Pain score assessed by numeric rating scale (NRS) 1 day after the operation	Patients are asked to rate their pain according to the numeric rating scale (NRS, 0=no pain to 10= extreme pain imaginable) 1 day after the operation. Higher NRS represents a worse outcome.	On 1 day after the operation
Total analgesic consumption after PACU discharge	Check the analgesic consumption after PACU discharge including oral, intramuscular and intravenous administration.	During 1 day after the operation
Intraoperative propofol consumption	The amount of propofol consumption during the operation	During the operation period (Within 2 hour after the anesthesia induction)
Intraoperative mean SPI	Check the SPI value throughout the operation using the vital recorder program.	Approximately during 2 hour after the anesthesia induction

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACU stay time	Duration of time interval from PACU admission to discharge.	Approximately within 1 hour after the PACU admission
Intraoperative vasopressor or vasodilator consumption	The amount of ephedrine and nicardipine consumption during the operation	During the operation period (Within 2 hour after the anesthesia induction)

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center

Publications and helpful links

General Publications

• Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): May 9, 2019
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: DCMC#6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No