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Comparison of total infused dose of remifentanil between pain threshold index monitoring group and control group
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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'. |
|
| Control group | Active Comparator | As conventional management, adjust infusion rate of remifentanil and propofol according to wavelet index and conventional vital signs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain threshold index | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Extubation time | Elapsed time from end of surgery to extubation | At the end of anesthesia, less than 1 hour |
| Post-anesthesia care unit length of stay | Length of stay at post-anesthesia care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang-Hwan Ji, M.D., M.S. | Contact | +82-10-9251-5019 | taepoongshin@gmail.com | |
| Young-Eun Jang, M.D., M.S. | Contact | +82-10-9487-2233 | na0ag2@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hee-Soo Kim, M.D., Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27171828 | Background | 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. | |
| 28489614 | Background | 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. |
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| Wavelet index | Device | 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 |
|
| At discharge from post-anesthesia care unit, less than 1 day |
| 25410376 | Background | 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. |
| 17329347 | Background | 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. |
| 22973178 | Background | 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. |
| 21051493 | Background | 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. |
| 24284309 | Background | 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. |
| 23220856 | Background | 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. |
| 27583920 | Background | 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. |
| 22324319 | Background | 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. |
| 28178175 | Background | 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. |
| 25815454 | Background | 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. |
| 28776544 | Background | 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. |