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Completed

NCT Number: NCT03586791

Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia

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).

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Key information

Conditions

Cholecystectomy, Laparoscopic Anesthesia, General Reflex, Pupillary

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eugene Kim

Daegu, Nam-gu, 42472, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pupillometry guided anesthesia

Procedure

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.

Other names: PUPIL

SPI guided anesthesia

Procedure

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.

Other names: SPI

Standard management

Procedure

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.

Other names: Control

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. Intraoperative propofol consumption

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

    The amount of propofol consumption during the operation

  2. Intraoperative vasopressor or vasodilator consumption

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

    The amount of ephedrine and nicardipine consumption during the operation

  3. PACU stay time

    Time frame: Approximately within 1 hour after the PACU admission

    Duration of time interval from PACU admission to discharge.

  4. Postoperative adverse events

    Time frame: Approximately within 1 hour after the PACU admission

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

  5. Remnant sedation degree

    Time frame: Approximately within 1 hour after the PACU admission

    Remnant sedation is evaluated by Riker Sedation-Agitation Scale every 10 minutes after the PACU admission.

    • unarousable, minimal or no response to noxious stimuli, does not communicate of follow commands
    • very sedate, arouse to physical stimuli but does not communicate or follow command, may move spontaneously
    • sedate, difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commands but drifts off again
    • Calm and cooperative, calm and follows commands
    • agitated, anxious or physically agitated and calms to verbal instructions
    • very agitated, requiring restraint and frequent verbal reminding of limits, biting endotracheal tubes
    • dangerous agitation, pulling at tracheal tube, trying to remove catheters or striking at staff

  6. Total analgesic consumption after PACU discharge

    Time frame: During 1 day after the operation

    Check the analgesic consumption after PACU discharge including oral, intramuscular and intravenous administration.

  7. Pain score assessed by numeric rating scale (NRS) 1 day after the operation

    Time frame: 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.

  8. initial Pupillary unrest under ambient light (PUAL)

    Time frame: 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.

  9. Pupillary unrest under ambient light (PUAL) on PACU arrival

    Time frame: 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.

Other outcomes

  1. Intraoperative pupil change

    Time frame: Approximately 2 hour after the anesthesia induction

    Measure the pupillary diameter every 5 minutes after the tracheal intubation until the end of operation.

  2. Intraoperative SPI change

    Time frame: Approximately 2 hour after the anesthesia induction

    Check the SPI value throughout the operation using the vital recorder program.

  3. Intraoperative mean blood pressure change

    Time frame: Approximately 2 hour after the anesthesia induction

    Check the mean arterial blood pressure throughout the operation using the vital recorder program.

  4. Intraoperative heart rate change

    Time frame: Approximately 2 hour after the anesthesia induction

    Check the heart rate throughout the operation using the vital recorder program.

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

Comparison of Pupillometry-guided With Surgical Pleth Index (SPI) Guided General Anesthesia on Perioperative Opioid Consumption and Pain Intensity: a Pilot Study

Acronym: PUPIL

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 16, 2018
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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