NCT03622242

Brief Summary

Comparison of total infused dose of remifentanil between pain threshold index monitoring group and control group

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

August 13, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

July 8, 2018

Last Update Submit

August 14, 2018

Conditions

ElectroencephalographyAnesthesia, General

Outcome Measures

Primary Outcomes (1)

  • Remifentanil consumption

    Total amount of infused remifentanil divided by patient's weight and total anesthesia time

    At the end of anesthesia, total anesthesia time less than 1 day

Secondary Outcomes (2)

  • Extubation time

    At the end of anesthesia, less than 1 hour

  • Post-anesthesia care unit length of stay

    At discharge from post-anesthesia care unit, less than 1 day

Study Arms (2)

Pain threshold index group

EXPERIMENTAL

Adjust infusion rate of remifentanil and propofol according to pain threshold index and wavelet index in 'pain threshold index group'.

Device: Pain threshold indexDevice: Wavelet index

Control group

ACTIVE COMPARATOR

As conventional management, adjust infusion rate of remifentanil and propofol according to wavelet index and conventional vital signs

Device: Wavelet index

Interventions

Pain threshold indexDEVICE

In pain threshold index monitor, monitor patients' pain threshold index based on electroencephalography and adjust infusion rate of remifentanil and propofol according to pain threshold index

Pain threshold index group
Wavelet indexDEVICE

In wavelet index monitor, monitor patients' wavelet index based on electroencephalography as an indicator of depth of anesthesia and adjust infusion rate of propofol according to wavelet index

Control groupPain threshold index group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children between 3 and 12 years old undergoing orthopedic surgery at extremities under general anesthesia

You may not qualify if:

  • History of adverse drug reactions to opioids
  • Underlying neurological disease or taking medication for neurologic purpose
  • Patients who were transferred to intensive care unit after the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (13)

  • Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.

    PMID: 27171828BACKGROUND

  • Funcke S, Sauerlaender S, Pinnschmidt HO, Saugel B, Bremer K, Reuter DA, Nitzschke R. Validation of Innovative Techniques for Monitoring Nociception during General Anesthesia: A Clinical Study Using Tetanic and Intracutaneous Electrical Stimulation. Anesthesiology. 2017 Aug;127(2):272-283. doi: 10.1097/ALN.0000000000001670.

    PMID: 28489614BACKGROUND

  • Constant I, Sabourdin N. Monitoring depth of anesthesia: from consciousness to nociception. A window on subcortical brain activity. Paediatr Anaesth. 2015 Jan;25(1):73-82. doi: 10.1111/pan.12586. Epub 2014 Nov 20.

    PMID: 25410376BACKGROUND

  • Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.

    PMID: 17329347BACKGROUND

  • Chen X, Thee C, Gruenewald M, Ilies C, Hocker J, Hanss R, Steinfath M, Bein B. Correlation of surgical pleth index with stress hormones during propofol-remifentanil anaesthesia. ScientificWorldJournal. 2012;2012:879158. doi: 10.1100/2012/879158. Epub 2012 Sep 2.

    PMID: 22973178BACKGROUND

  • Bonhomme V, Uutela K, Hans G, Maquoi I, Born JD, Brichant JF, Lamy M, Hans P. Comparison of the surgical Pleth Index with haemodynamic variables to assess nociception-anti-nociception balance during general anaesthesia. Br J Anaesth. 2011 Jan;106(1):101-11. doi: 10.1093/bja/aeq291. Epub 2010 Nov 4.

    PMID: 21051493BACKGROUND

  • Colombo R, Raimondi F, Corona A, Rivetti I, Pagani F, Porta VD, Guzzetti S. Comparison of the Surgical Pleth Index with autonomic nervous system modulation on cardiac activity during general anaesthesia: A randomised cross-over study. Eur J Anaesthesiol. 2014 Feb;31(2):76-84. doi: 10.1097/01.EJA.0000436116.06728.b3.

    PMID: 24284309BACKGROUND

  • Bergmann I, Gohner A, Crozier TA, Hesjedal B, Wiese CH, Popov AF, Bauer M, Hinz JM. Surgical pleth index-guided remifentanil administration reduces remifentanil and propofol consumption and shortens recovery times in outpatient anaesthesia. Br J Anaesth. 2013 Apr;110(4):622-8. doi: 10.1093/bja/aes426. Epub 2012 Dec 5.

    PMID: 23220856BACKGROUND

  • Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.

    PMID: 27583920BACKGROUND

  • Ilies C, Ludwigs J, Gruenewald M, Thee C, Hanf J, Hanss R, Steinfath M, Bein B. The effect of posture and anaesthetic technique on the surgical pleth index. Anaesthesia. 2012 May;67(5):508-513. doi: 10.1111/j.1365-2044.2011.07051.x. Epub 2012 Feb 11.

    PMID: 22324319BACKGROUND

  • Won YJ, Lim BG, Yeo GE, Lee MK, Lee DK, Kim H, Lee IO, Kong MH. The effect of nicardipine on the surgical pleth index during thyroidectomy under general anesthesia: A prospective double-blind randomized controlled trial. Medicine (Baltimore). 2017 Feb;96(6):e6154. doi: 10.1097/MD.0000000000006154.

    PMID: 28178175BACKGROUND

  • Park JH, Lim BG, Kim H, Lee IO, Kong MH, Kim NS. Comparison of Surgical Pleth Index-guided Analgesia with Conventional Analgesia Practices in Children: A Randomized Controlled Trial. Anesthesiology. 2015 Jun;122(6):1280-7. doi: 10.1097/ALN.0000000000000650.

    PMID: 25815454BACKGROUND

  • An JX, Wang Y, Cope DK, Williams JP. Quantitative Evaluation of Pain with Pain Index Extracted from Electroencephalogram. Chin Med J (Engl). 2017 Aug 20;130(16):1926-1931. doi: 10.4103/0366-6999.211878.

    PMID: 28776544BACKGROUND

Study Officials

  • Hee-Soo Kim, M.D., Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-Hwan Ji, M.D., M.S.

CONTACT

+82-10-9251-5019taepoongshin@gmail.com

Young-Eun Jang, M.D., M.S.

CONTACT

+82-10-9487-2233na0ag2@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 8, 2018

First Posted

August 9, 2018

Study Start

August 13, 2018

Primary Completion

June 30, 2019

Study Completion

July 31, 2019

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

KR(1)