Effect of Pupilometer Guided Analgesia on Postoperative Pain

Not Applicable

Completed

• Conditions: Reflex, Pupillary; Anesthesia, General; Cholecystectomy, Laparoscopic
• Interventions: Procedure: SPI guided anesthesia; Procedure: Pupilometer guided anesthesia

• Registration Number: NCT03794271
• 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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Primary Completion: 2019-05-09
• Study Completion: 2019-05-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPI group	SPI guided anesthesia	In this group, intraoperative analgesia is performed using SPI guided anesthesia
Pupilometer group	Pupilometer guided anesthesia	In this group, intraoperative analgesia is performed using pupilometer guided anesthesia.

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.

Secondary Outcome Measures

Name	Time	Method
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.
Intraoperative propofol consumption	During the operation period (Within 2 hour after the anesthesia induction)	The amount of propofol consumption during the operation
Intraoperative mean SPI	Approximately during 2 hour after the anesthesia induction	Check the SPI value throughout the operation using the vital recorder program.
Intraoperative remifentanil consumption rate	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)
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 (RSA) 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; 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	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.

Trial Locations

Locations (1)

Eugene Kim; 🇰🇷 Daegu, Nam-gu, Korea, Republic of