Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children (PURFT)
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|ClinicalTrials.gov Identifier: NCT03749811|
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use||Device: Pupillometry||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Interventional group: remifentanil infusion under pupillometry monitoring. Control group: remifentanil infusion without pupillometry monitoring (remifentanil dose is determined by conventional method, i. e., hemodynamic change probably related to noxious stimuli)|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
Participant does not know in which of the groups he/she is allocated. Only a care provider (an attending anesthesiologist who is responsible for the patient's anesthesia) knows the group which the patient belongs to.
Investigator and outcomes assessor does not know in which of the groups the patient is allocated, since the group name will be just recorded as "A" or "B" until data analysis of the last participant is done.
|Official Title:||Comparison of Remifentanil Consumption in Pupillometry-guided Versus Conventional Administration in Pediatric Surgery: a Prospective, Randomized Controlled Trial|
|Actual Study Start Date :||December 4, 2018|
|Estimated Primary Completion Date :||November 18, 2020|
|Estimated Study Completion Date :||November 18, 2021|
Experimental: Pupillometry group
A group of participants who receive remifentanil infusion under pupillometry monitoring.
After induction of anesthesia and determination of the loss of consciousness of the participant, baseline diameter of pupil is measured by electronic pupillometry device. During anesthesia, participant's pupil diameter is repeatedly measured with 5-minute interval. Pupil dilation of 30% or more compared to baseline is indicative of insufficient analgesia.
No Intervention: Conventional group
A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change.
- remifentanil total dose in microgram [ Time Frame: from beginning of anesthesia to the end of the anesthesia ]Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).
- FLACC score [ Time Frame: Arrival at the post-anesthesia care unit ]FLACC score (a pain evaluation method for children who cannot express their severity of pain verbally) right after post-anesthesia care unit arrival.
- Adjusted analgesic dose after anesthesia [ Time Frame: 24 hours after the end of anesthesia ]Total dose of analgesics (NSAIDs and opioids) delivered to the patient since the end of the anesthesia, until 24 hours after the end of anesthesia
- Emergence time [ Time Frame: Intraoperative ]Time between the end of the surgery and extubation
- Incidence of rescue therapy [ Time Frame: Intraoperative ]Incidence of vasopressor/inotropics/anticholinergics/fluid/vasodilators administered, due to moderate to severe hemodynamic change
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749811
|Contact: Hee-Soo Kim, M.D., Ph.D.||+email@example.com|
|Contact: Sang-Whan Jifirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Heesoo Kim|
|Principal Investigator:||Hee-Soo Kim, M.D., Ph.D.||Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital|