Effect of Pupilometer Guided Analgesia on Postoperative Pain (PUPIL_pain)
Primary Purpose
Cholecystectomy, Laparoscopic, Anesthesia, General, Reflex, Pupillary
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pupilometer guided anesthesia
SPI guided anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Cholecystectomy, Laparoscopic
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
Sites / Locations
- Eugene Kim
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pupilometer group
SPI group
Arm Description
In this group, intraoperative analgesia is performed using pupilometer guided anesthesia.
In this group, intraoperative analgesia is performed using SPI guided anesthesia
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Postoperative adverse events
Check the postoperative nausea and vomiting, dizziness, desaturation, urinary retention, itching sensation and bradycardia
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.
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.
Total analgesic consumption after PACU discharge
Check the analgesic consumption after PACU discharge including oral, intramuscular and intravenous administration.
Intraoperative propofol consumption
The amount of propofol consumption during the operation
Intraoperative mean SPI
Check the SPI value throughout the operation using the vital recorder program.
Full Information
NCT ID
NCT03794271
First Posted
January 3, 2019
Last Updated
August 9, 2019
Sponsor
Daegu Catholic University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03794271
Brief Title
Effect of Pupilometer Guided Analgesia on Postoperative Pain
Acronym
PUPIL_pain
Official Title
Effect of Pupilometer Guided Analgesia on Postoperative Pain Intensity and Perioperative Complications
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
May 9, 2019 (Actual)
Study Completion Date
May 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daegu Catholic University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystectomy, Laparoscopic, Anesthesia, General, Reflex, Pupillary
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pupilometer group
Arm Type
Experimental
Arm Description
In this group, intraoperative analgesia is performed using pupilometer guided anesthesia.
Arm Title
SPI group
Arm Type
Active Comparator
Arm Description
In this group, intraoperative analgesia is performed using SPI guided anesthesia
Intervention Type
Procedure
Intervention Name(s)
Pupilometer guided anesthesia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
SPI guided anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)
Description
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.
Time Frame
During the PACU stay (Within 1 hour after the PACU admission)
Secondary Outcome Measure Information:
Title
Intraoperative remifentanil consumption rate
Description
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)
Time Frame
During the operation period (Within 2 hour after the anesthesia induction)
Title
Postoperative adverse events
Description
Check the postoperative nausea and vomiting, dizziness, desaturation, urinary retention, itching sensation and bradycardia
Time Frame
Approximately within 1 hour after the PACU admission
Title
Remnant sedation degree
Description
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.
Time Frame
Approximately within 1 hour after the PACU admission
Title
Pain score assessed by numeric rating scale (NRS) 1 day after the operation
Description
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.
Time Frame
On 1 day after the operation
Title
Total analgesic consumption after PACU discharge
Description
Check the analgesic consumption after PACU discharge including oral, intramuscular and intravenous administration.
Time Frame
During 1 day after the operation
Title
Intraoperative propofol consumption
Description
The amount of propofol consumption during the operation
Time Frame
During the operation period (Within 2 hour after the anesthesia induction)
Title
Intraoperative mean SPI
Description
Check the SPI value throughout the operation using the vital recorder program.
Time Frame
Approximately during 2 hour after the anesthesia induction
Other Pre-specified Outcome Measures:
Title
PACU stay time
Description
Duration of time interval from PACU admission to discharge.
Time Frame
Approximately within 1 hour after the PACU admission
Title
Intraoperative vasopressor or vasodilator consumption
Description
The amount of ephedrine and nicardipine consumption during the operation
Time Frame
During the operation period (Within 2 hour after the anesthesia induction)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Kim, MD, PhD
Organizational Affiliation
Assistant professor
Official's Role
Study Chair
Facility Information:
Facility Name
Eugene Kim
City
Daegu
State/Province
Nam-gu
ZIP/Postal Code
42472
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25988634
Citation
Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.
Results Reference
background
PubMed Identifier
17023285
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.
Results Reference
background
PubMed Identifier
28719527
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.
Results Reference
background
PubMed Identifier
27941575
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.
Results Reference
background
PubMed Identifier
27543532
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.
Results Reference
background
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Effect of Pupilometer Guided Analgesia on Postoperative Pain
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