Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pupillometry group | Experimental | In this group, anesthesia is performed using Pupillometry guided anesthesia. |
|
| SPI group | Active Comparator | In this group, anesthesia is performed using SPI guided anesthesia. |
|
| Control group | Sham Comparator | In this group, remifentanil concentration is controlled by the discretion of the anesthesiologist in charge of the patients (Standard management). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pupillometry guided anesthesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative propofol consumption | The amount of propofol consumption during the operation | During the operation period (Within 2 hour after the anesthesia induction) |
| Intraoperative vasopressor or vasodilator consumption |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Intraoperative SPI change |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eugene Kim, MD, PhD | Assistant professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eugene Kim | Daegu | Nam-gu | 42472 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25988634 | Background | Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314. | |
| 17023285 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| SPI guided anesthesia | Procedure | 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 | Procedure | 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. |
|
|
The amount of ephedrine and nicardipine consumption during the operation
| During the operation period (Within 2 hour after the anesthesia induction) |
| PACU stay time | Duration of time interval from PACU admission to discharge. | Approximately within 1 hour after the PACU admission |
| 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 Scale every 10 minutes after the PACU admission.
| Approximately within 1 hour after the PACU admission |
| 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 |
| 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 |
| 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 |
| 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 |
Check the SPI value throughout the operation using the vital recorder program.
| Approximately 2 hour after the anesthesia induction |
| 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 |
| Intraoperative heart rate change | Check the heart rate throughout the operation using the vital recorder program. | Approximately 2 hour after the anesthesia induction |
| 28719527 | Background | 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. |
| 27941575 | Background | 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. |
| 27543532 | Background | 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. |
| 33079883 | Derived | 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. |