Comparison of Pupillometry-guided With Surgical Pleth Index (SPI) Guided General Anesthesia on Perioperative Opioid Consumption and Pain Intensity: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cholecystectomy, Laparoscopic
- Sponsor
- Daegu Catholic University Medical Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eugene Kim
Assistant professor
Daegu Catholic University Medical Center
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
Outcomes
Primary Outcomes
Peak pain score assessed by numeric rating scale (NRS) in post-anesthesia care unit (PACU)
Time Frame: 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
Time Frame: 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 Outcomes
- Postoperative adverse events(Approximately within 1 hour after the PACU admission)
- Remnant sedation degree(Approximately within 1 hour after the PACU admission)
- Pain score assessed by numeric rating scale (NRS) 1 day after the operation(On 1 day after the operation)
- Intraoperative propofol consumption(During the operation period (Within 2 hour after the anesthesia induction))
- Intraoperative vasopressor or vasodilator consumption(During the operation period (Within 2 hour after the anesthesia induction))
- PACU stay time(Approximately within 1 hour after the PACU admission)
- Total analgesic consumption after PACU discharge(During 1 day after the operation)
- initial Pupillary unrest under ambient light (PUAL)(Just before the induction of anesthesia)
- Pupillary unrest under ambient light (PUAL) on PACU arrival(Approximately within 1 min after the PACU admission)