Study Results
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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UNKNOWN
NA
180 participants
INTERVENTIONAL
2018-08-13
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Pain threshold index group
Adjust infusion rate of remifentanil and propofol according to pain threshold index and wavelet index in 'pain threshold index group'.
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
Control group
As conventional management, adjust infusion rate of remifentanil and propofol according to wavelet index and conventional vital signs
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Underlying neurological disease or taking medication for neurologic purpose
* Patients who were transferred to intensive care unit after the surgery
3 Years
12 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Hee-Soo Kim
professor
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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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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D-1804-059-936
Identifier Type: -
Identifier Source: org_study_id
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