Pupillometer as a Pain Index During General Anesthesia

Pain Clinical Trial

Official title:

Validity of Pupil Diameter for Pain Monitoring During General Anesthesia in Children : a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062864
• Other study ID #: 1906-121-1043
• Status: Completed
• Start date: August 21, 2019
• Est. completion date: July 24, 2020

Study information

• Verified date: August 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 24, 2020
• Est. primary completion date: July 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General
• Pain
• Pupil

Intervention

Device:
• Pupil size
Measures the diameter of pupil before and after painful stimuli

Locations

Country	Name	City	State
Korea, Republic of	SNUH	Seoul	Jongno Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

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. — View Citation

Höfle 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2005 Mar 16. — View Citation

Paulus J, Roquilly A, Beloeil H, Théraud 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Urban BW, Bleckwenn M. Concepts and correlations relevant to general anaesthesia. Br J Anaesth. 2002 Jul;89(1):3-16. Review. — View Citation

Wessel DL. Hemodynamic responses to perioperative pain and stress in infants. Crit Care Med. 1993 Sep;21(9 Suppl):S361-2. Review. — View Citation

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 Apr 19. doi: 10.1111/aas.13129. [Epub ahead of print] — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil diameter	Pupil diameter before and after painful stimuli (skin incision, train-of-four stimulation)	From start of anesthesia to end of anesthesia
Secondary	Bispectral index	Bispectral index before and after painful stimuli (skin incision, train-of-four stimulation)	From start of anesthesia to end of anesthesia
Secondary	Pleth variability index	Pleth variability index before and after painful stimuli (skin incision, train-of-four stimulation)	From start of anesthesia to end of anesthesia