Pupillometer as a Pain Index During General Anesthesia

NCT ID: NCT04062864

Last Updated: 2020-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-21

Study Completion Date

2020-07-24

Brief Summary

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

Detailed Description

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Pupil diameter is known to be strongly correlated with sympathetic tone. During surgery under general anesthesia, there is no standardized means of pain assessment. As pain activates sympathetic nervous system, we hypothesized that pupil diameter can be a marker for pain during surgery.

Conditions

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Anesthesia, General Pupil Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Pupil size

Measures the diameter of pupil before and after painful stimuli

Intervention Type DEVICE

Other Intervention Names

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Pupillometer

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee-Soo Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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SNUH

Seoul, Jongno Gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 22446982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12925472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18644409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30032886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28526162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29739534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15791504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23883683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28719527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27717898 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29739543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12173238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8365227 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29671874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30198405 (View on PubMed)

Other Identifiers

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1906-121-1043

Identifier Type: -

Identifier Source: org_study_id

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