Anesthesia, General, Cholecystectomy, Laparoscopic, Reflex, Pupillary
Conditions
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).
Interventions
PROCEDUREPupillometry 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.
PROCEDURESPI 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.
PROCEDUREStandard 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.
Sponsors
Daegu Catholic University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative opioid consumption | During the operation period (Within 2 hour after the anesthesia induction) | 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) |
| Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU) | During the PACU stay (Within 1 hour after the PACU admission) | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative adverse events | Approximately within 1 hour after the PACU admission | Check the postoperative nausea and vomiting, dizziness, desaturation, urinary retention, itching sensation and bradycardia |
| Total analgesic consumption after PACU discharge | During 1 day after the operation | Check the analgesic consumption after PACU discharge including oral, intramuscular and intravenous administration. |
| Pain score assessed by numeric rating scale (NRS) 1 day after the operation | On 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. |
| initial Pupillary unrest under ambient light (PUAL) | Just before the induction of anesthesia | 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. |
| Pupillary unrest under ambient light (PUAL) on PACU arrival | Approximately within 1 min after the PACU admission | 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. |
| Intraoperative propofol consumption | During the operation period (Within 2 hour after the anesthesia induction) | The amount of propofol consumption during the operation |
| Intraoperative vasopressor or vasodilator consumption | During the operation period (Within 2 hour after the anesthesia induction) | The amount of ephedrine and nicardipine consumption during the operation |
| PACU stay time | Approximately within 1 hour after the PACU admission | Duration of time interval from PACU admission to discharge. |
| Remnant sedation degree | Approximately within 1 hour after the PACU admission | Remnant sedation is evaluated by Riker Sedation-Agitation Scale every 10 minutes after the PACU admission. 1. unarousable, minimal or no response to noxious stimuli, does not communicate of follow commands 2. very sedate, arouse to physical stimuli but does not communicate or follow command, may move spontaneously 3. sedate, difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commands but drifts off again 4. Calm and cooperative, calm and follows commands 5. agitated, anxious or physically agitated and calms to verbal instructions 6. very agitated, requiring restraint and frequent verbal reminding of limits, biting endotracheal tubes 7. dangerous agitation, pulling at tracheal tube, trying to remove catheters or striking at staff |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative heart rate change | Approximately 2 hour after the anesthesia induction | Check the heart rate throughout the operation using the vital recorder program. |
| Intraoperative pupil change | Approximately 2 hour after the anesthesia induction | Measure the pupillary diameter every 5 minutes after the tracheal intubation until the end of operation. |
| Intraoperative SPI change | Approximately 2 hour after the anesthesia induction | Check the SPI value throughout the operation using the vital recorder program. |
| Intraoperative mean blood pressure change | Approximately 2 hour after the anesthesia induction | Check the mean arterial blood pressure throughout the operation using the vital recorder program. |
Countries
South Korea
Outcome results
None listed