NCT04062864

Brief Summary

This study evaluates the validity of pupil diameter as an indicator of pain during surgery under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 21, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

August 18, 2019

Last Update Submit

August 12, 2020

Conditions

Anesthesia, GeneralPupilPain

Outcome Measures

Primary Outcomes (1)

  • Pupil diameter

    Pupil diameter before and after painful stimuli (skin incision, train-of-four stimulation)

    From start of anesthesia to end of anesthesia

Secondary Outcomes (2)

  • Bispectral index

    From start of anesthesia to end of anesthesia

  • Pleth variability index

    From start of anesthesia to end of anesthesia

Interventions

Pupil sizeDEVICE

Measures the diameter of pupil before and after painful stimuli

Also known as: Pupillometer

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children undergoing surgery under general anesthesia at Seoul National University Hospital

You may qualify if:

  • Children undergoing surgery under general anesthesia with total time of less than two hours

You may not qualify if:

  • Children whose parent or legal guardian declined to enroll
  • Any use of opioids during surgery
  • History of hypersensitivity to any anesthetic agents
  • Any medication that can affect sympathetic nervous activity
  • Presence of underlying ophthalmologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, Jongno Gu, 15710, South Korea

Location

Related Publications (15)

  • Aissou M, Snauwaert A, Dupuis C, Atchabahian A, Aubrun F, Beaussier M. Objective assessment of the immediate postoperative analgesia using pupillary reflex measurement: a prospective and observational study. Anesthesiology. 2012 May;116(5):1006-12. doi: 10.1097/ALN.0b013e318251d1fb.

    PMID: 22446982BACKGROUND

  • Barvais L, Engelman E, Eba JM, Coussaert E, Cantraine F, Kenny GN. Effect site concentrations of remifentanil and pupil response to noxious stimulation. Br J Anaesth. 2003 Sep;91(3):347-52. doi: 10.1093/bja/aeg178.

    PMID: 12925472BACKGROUND

  • Hofle M, Kenntner-Mabiala R, Pauli P, Alpers GW. You can see pain in the eye: pupillometry as an index of pain intensity under different luminance conditions. Int J Psychophysiol. 2008 Dec;70(3):171-5. doi: 10.1016/j.ijpsycho.2008.06.008. Epub 2008 Jun 28.

    PMID: 18644409BACKGROUND

  • Julien-Marsollier F, Rachdi K, Caballero MJ, Ayanmanesh F, Vacher T, Horlin AL, Skhiri A, Brasher C, Michelet D, Dahmani S. Evaluation of the analgesia nociception index for monitoring intraoperative analgesia in children. Br J Anaesth. 2018 Aug;121(2):462-468. doi: 10.1016/j.bja.2018.03.034. Epub 2018 Jun 5.

    PMID: 30032886BACKGROUND

  • Kaye AD, Fox CJ, Padnos IW, Ehrhardt KP Jr, Diaz JH, Cornett EM, Chandler D, Sen S, Patil S. Pharmacologic Considerations of Anesthetic Agents in Pediatric Patients: A Comprehensive Review. Anesthesiol Clin. 2017 Jun;35(2):e73-e94. doi: 10.1016/j.anclin.2017.01.012. Epub 2017 Apr 14.

    PMID: 28526162BACKGROUND

  • Mulier J, Dekock M. Opioid free general anesthesia, a new paradigm? Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):441-443. doi: 10.1016/j.bpa.2017.11.005. Epub 2017 Dec 6. No abstract available.

    PMID: 29739534BACKGROUND

  • Muller MP, Tomlinson G, Marrie TJ, Tang P, McGeer A, Low DE, Detsky AS, Gold WL. Can routine laboratory tests discriminate between severe acute respiratory syndrome and other causes of community-acquired pneumonia? Clin Infect Dis. 2005 Apr 15;40(8):1079-86. doi: 10.1086/428577. Epub 2005 Mar 16.

    PMID: 15791504BACKGROUND

  • Paulus J, Roquilly A, Beloeil H, Theraud J, Asehnoune K, Lejus C. Pupillary reflex measurement predicts insufficient analgesia before endotracheal suctioning in critically ill patients. Crit Care. 2013 Jul 24;17(4):R161. doi: 10.1186/cc12840.

    PMID: 23883683BACKGROUND

  • Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.

    PMID: 28719527BACKGROUND

  • Silins V, Brasher C, Antus F, Michelet D, Hilly J, Grace R, Dahmani S. Predicting postoperative morphine consumption in children. Anaesth Crit Care Pain Med. 2017 Jun;36(3):179-184. doi: 10.1016/j.accpm.2016.08.005. Epub 2016 Oct 4.

    PMID: 27717898BACKGROUND

  • Sultana A, Torres D, Schumann R. Special indications for Opioid Free Anaesthesia and Analgesia, patient and procedure related: Including obesity, sleep apnoea, chronic obstructive pulmonary disease, complex regional pain syndromes, opioid addiction and cancer surgery. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):547-560. doi: 10.1016/j.bpa.2017.11.002. Epub 2017 Nov 16.

    PMID: 29739543BACKGROUND

  • Urban BW, Bleckwenn M. Concepts and correlations relevant to general anaesthesia. Br J Anaesth. 2002 Jul;89(1):3-16. doi: 10.1093/bja/aef164. No abstract available.

    PMID: 12173238BACKGROUND

  • Wessel DL. Hemodynamic responses to perioperative pain and stress in infants. Crit Care Med. 1993 Sep;21(9 Suppl):S361-2. doi: 10.1097/00003246-199309001-00037. No abstract available.

    PMID: 8365227BACKGROUND

  • Wildemeersch D, Peeters N, Saldien V, Vercauteren M, Hans G. Pain assessment by pupil dilation reflex in response to noxious stimulation in anaesthetized adults. Acta Anaesthesiol Scand. 2018 Sep;62(8):1050-1056. doi: 10.1111/aas.13129. Epub 2018 Apr 19.

    PMID: 29671874BACKGROUND

  • Won YJ, Lim BG, Kim YS, Lee M, Kim H. Usefulness of surgical pleth index-guided analgesia during general anesthesia: a systematic review and meta-analysis of randomized controlled trials. J Int Med Res. 2018 Nov;46(11):4386-4398. doi: 10.1177/0300060518796749. Epub 2018 Sep 9.

    PMID: 30198405BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hee-Soo Kim, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2019

First Posted

August 20, 2019

Study Start

August 21, 2019

Primary Completion

July 24, 2020

Study Completion

July 24, 2020

Last Updated

August 13, 2020

Record last verified: 2020-08

Locations

KR(1)