Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia

Anesthesia, General Clinical Trial

— PUPIL  

Official title:

Comparison of Pupillometry-guided With Surgical Pleth Index (SPI) Guided General Anesthesia on Perioperative Opioid Consumption and Pain Intensity: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586791
• Other study ID #: DCMC#5
• Status: Completed
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: October 2019
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Pupillometry 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.
• 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.
• Standard management
During the operation, propofol effect-site target concentration (Ce) is adjusted to maintain the bispectral index (BIS) value between 40 and 60. Remifentanil concentration is controlled by the discretion of the anesthesiologist in charge of the patients.

Locations

Country	Name	City	State
Korea, Republic of	Eugene Kim	Daegu	Nam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. Epub 2006 Aug 8. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraoperative pupil change	Measure the pupillary diameter every 5 minutes after the tracheal intubation until the end of operation.	Approximately 2 hour after the anesthesia induction
Other	Intraoperative SPI change	Check the SPI value throughout the operation using the vital recorder program.	Approximately 2 hour after the anesthesia induction
Other	Intraoperative mean blood pressure change	Check the mean arterial blood pressure throughout the operation using the vital recorder program.	Approximately 2 hour after the anesthesia induction
Other	Intraoperative heart rate change	Check the heart rate throughout the operation using the vital recorder program.	Approximately 2 hour after the anesthesia induction
Primary	Intraoperative opioid consumption	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)
Primary	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	Intraoperative propofol consumption	The amount of propofol consumption during the operation	During the operation period (Within 2 hour after the anesthesia induction)
Secondary	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)
Secondary	PACU stay time	Duration of time interval from PACU admission to discharge.	Approximately within 1 hour after the PACU admission
Secondary	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
Secondary	Remnant sedation degree	Remnant sedation is evaluated by Riker Sedation-Agitation 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	Approximately within 1 hour after the PACU admission
Secondary	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
Secondary	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
Secondary	initial Pupillary unrest under ambient light (PUAL)	At room light, the pupil is taken for 8 seconds at a frame rate of 30 frames per second. The pupillometer generates raw data in the format of pupil diameter versus time. We define the PUAL as the area under the curve of power spectral density between 0.23 and 3 Hz. The integral of the area is calculated using the composite Simpson's rule.	Just before the induction of anesthesia
Secondary	Pupillary unrest under ambient light (PUAL) on PACU arrival	At room light, the pupil is taken for 8 seconds at a frame rate of 30 frames per second. The pupillometer generates raw data in the format of pupil diameter versus time. We define the PUAL as the area under the curve of power spectral density between 0.23 and 3 Hz. The integral of the area is calculated using the composite Simpson's rule.	Approximately within 1 min after the PACU admission