Validity of Pain Threshold Index in Children

Anesthesia, General Clinical Trial

Official title:

Validity of Pain Threshold Index Based on Electroencephalogram for Pediatric Patients Under General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03622242
• Other study ID #: D-1804-059-936
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2018
• Source: Seoul National University Hospital
• Contact: Sang-Hwan Ji, M.D., M.S.
• Phone: +82-10-9251-5019
• Email: taepoongshin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Investigators plan to enroll pediatric patients aged between 3 and 12 years old undergoing surgery under general anesthesia with continuous infusion of 2% propofol and remifentanil.

After dividing them into two groups, investigators monitor pain threshold index and wavelet index in test group and adjust remifentanil infusion to maintain both indices in desirable range, while monitoring only wavelet index and adjust remifentanil infusion to maintain wavelet index and conventional vital signs in desirable range in control group.

Investigators compare consumption of remifentanil, time to extubation after surgery, and post-anesthesia care unit length of stay between both groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia, General
• Electroencephalography

Intervention

Device:
• Pain threshold index
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
• Wavelet index
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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

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. — View Citation

Bergmann I, Göhner 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. — View Citation

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. — View Citation

Chen X, Thee C, Gruenewald M, Ilies C, Höcker 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Huiku M, Uutela K, van Gils M, Korhonen I, Kymäläinen M, Meriläinen P, Paloheimo M, Rantanen M, Takala P, Viertiö-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. Epub 2007 Feb 28. — View Citation

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):508-13. doi: 10.1111/j.1365-2044.2011.07051.x. Epub 2012 Feb 11. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Extubation time	Elapsed time from end of surgery to extubation	At the end of anesthesia, less than 1 hour
Secondary	Post-anesthesia care unit length of stay	Length of stay at post-anesthesia care unit	At discharge from post-anesthesia care unit, less than 1 day