Effect of Pupilometer Guided Analgesia on Postoperative Pain

Daegu Catholic University Medical Center84 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Cholecystectomy, Laparoscopic Anesthesia, General Reflex, Pupillary

Interventions

Pupilometer guided anesthesiaPROCEDURE

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.

SPI guided anesthesiaPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Eugene Kim

Daegu, Nam-gu, South Korea

Outcomes

Primary Outcomes

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.

Time frame: During the PACU stay (Within 1 hour after the PACU admission)

Secondary Outcomes

Intraoperative remifentanil consumption rate

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)

Time frame: During the operation period (Within 2 hour after the anesthesia induction)

Postoperative adverse events

Check the postoperative nausea and vomiting, dizziness, desaturation, urinary retention, itching sensation and bradycardia

Time frame: Approximately within 1 hour after the PACU admission

Remnant sedation degree

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.

Time frame: Approximately within 1 hour after the PACU admission

Data from ClinicalTrials.gov

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