Effect of Pupilometer Guided Analgesia on Postoperative Pain (PUPIL_pain)
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|ClinicalTrials.gov Identifier: NCT03794271|
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cholecystectomy, Laparoscopic Anesthesia, General Reflex, Pupillary||Procedure: Pupilometer guided anesthesia Procedure: SPI guided anesthesia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effect of Pupilometer Guided Analgesia on Postoperative Pain Intensity and Perioperative Complications|
|Actual Study Start Date :||January 3, 2019|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Pupilometer group
In this group, intraoperative analgesia is performed using pupilometer guided anesthesia.
Procedure: Pupilometer guided anesthesia
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.
Active Comparator: SPI group
In this group, intraoperative analgesia is performed using SPI guided anesthesia
Procedure: SPI guided anesthesia
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.
- 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 remifentanil consumption rate [ 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)
- 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
- Remnant sedation degree [ Time Frame: 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.
- 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
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 [ 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.
- 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.
- Intraoperative propofol consumption [ Time Frame: During the operation period (Within 2 hour after the anesthesia induction) ]The amount of propofol consumption during the operation
- Intraoperative mean SPI [ Time Frame: Approximately during 2 hour after the anesthesia induction ]Check the SPI value throughout the operation using the vital recorder program.
- PACU stay time [ Time Frame: Approximately within 1 hour after the PACU admission ]Duration of time interval from PACU admission to discharge.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794271
|Contact: Eugene Kim, MD, PhDfirstname.lastname@example.org|
|Contact: JongHae Kim, MDemail@example.com|
|Korea, Republic of|
|Daegu, Nam-gu, Korea, Republic of, 42472|
|Contact: Eugene Kim, MD, PhD 82536503265 firstname.lastname@example.org|
|Contact: JongHae Kim, MD 82536504979 email@example.com|
|Principal Investigator: Eugene Kim, MD, PhD|
|Sub-Investigator: JongHae Kim, MD|
|Study Chair:||Eugene Kim, MD, PhD||Assistant professor|