Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia
- Conditions
- Cholecystectomy, LaparoscopicReflex, PupillaryAnesthesia, General
- Interventions
- Procedure: Pupillometry guided anesthesiaProcedure: SPI guided anesthesiaProcedure: Standard management
- Registration Number
- NCT03586791
- Lead Sponsor
- Daegu Catholic University Medical Center
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pupillometry group Pupillometry guided anesthesia In this group, anesthesia is performed using Pupillometry guided anesthesia. SPI group SPI guided anesthesia In this group, anesthesia is performed using SPI guided anesthesia. Control group Standard management In this group, remifentanil concentration is controlled by the discretion of the anesthesiologist in charge of the patients (Standard management).
- Primary Outcome Measures
Name Time Method 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.
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)
- Secondary Outcome Measures
Name Time Method 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
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 staffPain 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.
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.
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.
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.
Trial Locations
- Locations (1)
Eugene Kim
🇰🇷Daegu, Nam-gu, Korea, Republic of