Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Pupilometer Guided Analgesia on Postoperative Pain (PUPIL_pain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03794271
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
JongHae Kim, 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).

Condition or disease Intervention/treatment Phase
Cholecystectomy, Laparoscopic Anesthesia, General Reflex, Pupillary Procedure: Pupilometer guided anesthesia Procedure: SPI guided anesthesia Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)


  2. 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

  3. 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.

    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.


  4. 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.

  5. 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.

  6. Intraoperative propofol consumption [ Time Frame: During the operation period (Within 2 hour after the anesthesia induction) ]
    The amount of propofol consumption during the operation

  7. 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.


Other Outcome Measures:
  1. PACU stay time [ Time Frame: Approximately within 1 hour after the PACU admission ]
    Duration of time interval from PACU admission to discharge.

  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Eugene Kim, MD, PhD 82536503265 tomomie@hanmail.net
Contact: JongHae Kim, MD 82536504979 usmed@cu.ac.kr

Locations
Layout table for location information
Korea, Republic of
Eugene Kim Recruiting
Daegu, Nam-gu, Korea, Republic of, 42472
Contact: Eugene Kim, MD, PhD    82536503265    tomomie@hanmail.net   
Contact: JongHae Kim, MD    82536504979    usmed@cu.ac.kr   
Principal Investigator: Eugene Kim, MD, PhD         
Sub-Investigator: JongHae Kim, MD         
Sponsors and Collaborators
Daegu Catholic University Medical Center
Investigators
Layout table for investigator information
Study Chair: Eugene Kim, MD, PhD Assistant professor

Publications:
Layout table for additonal information
Responsible Party: JongHae Kim, Associate professor, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT03794271     History of Changes
Other Study ID Numbers: DCMC#6
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs