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Experimental measurement of analgesia during anesthesia


- candidate number16061
- NTR NumberNTR4401
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jan-2014
- Secondary IDsNL43511.058.13  
- Public TitleExperimental measurement of analgesia during anesthesia
- Scientific TitleMeasurement of nociceptive index during general anesthesia in ASA 1‐3 patients undergoing elective surgery using the Nociception Level (NoL) index
- ACRONYM
- hypothesisWe hypothize that higher opioid doses will lead to a lower NOL.
- Healt Condition(s) or Problem(s) studiedNociception, Analgesia, Intraoperative pain-measurement
- Inclusion criteriaAge: 18‐80 years; Sex: male or female; Surgery: Any surgery under general anesthesia; ASA status: 1, 2 or 3.
- Exclusion criteriaAge: < 18 or > 80 years; Unable to give written informed consent; Pregnancy/lactation; Extreme obesity: BMI > 35; Perceived difficult intubation. Patients requiring a rapid sequence induction Patients on beta‐blockers
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-okt-2013
- planned closingdate1-okt-2014
- Target number of participants100
- InterventionsStudy groups: Group 1 (n = 12): PROPOFOL ONLY GROUP. In this study group measurements will be obtained before intubation or opioid administration. To that end plasma propofol concentration will be increased slowly from 0 to 4 μg/ml in steps of 0.5 μg/mL. After the highest target is reached, the propofol target concentration will be lowered to get a BIS value of 50. After 5‐min, the laryngoscope will be inserted into the mouth. Next the laryngoscope will be removed. After 5‐min the laryngoscope will be placed again and the patient will be intubated. Group 2 (n = 12): PROPOFOL + REMIFENTANIL TARGET A. The subject will be intubated according to the design of group 1. The propofol concentration will be 1‐2 μg/kg, aimed at a BIS of 50, with 1 ng/ml remifentanil. Group 3 (n = 12): PROPOFOL + REMIFENTANIL TARGET B. The subject will be intubated according to the design of group 1. The propofol concentration will be 1‐2 μg/kg, aimed at a BIS of 50, with 2 ng/ml remifentanil Group 4 (n = 12): PROPOFOL + REMIFENTANIL TARGET C. The subject will be intubated according to the design of group 1. The propofol concentration will be 1‐2 μg/kg, aimed at a BIS of 50, with 3 ng/ml remifentanil. Group 5 (n = 12): PROPOFOL + REMIFENTANIL TARGET D. The subject will be intubated according to the design of group 1. The propofol concentration will be 1‐2 μg/kg, aimed at a BIS of 50, with 4 ng/ml remifentanil. Group 6 (n = 12): PROPOFOL + REMIFENTANIL TARGET E. The subject will be intubated according to the design of group 1. The propofol concentration will be 1‐2 μg/kg, aimed at a BIS of 50, with 5 ng/ml remifentanil. Group 7 (n = 12): PROPOFOL + REMIFENTANIL TARGET C. The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS of 30. Group 8 (n = 12): PROPOFOL + REMIFENTANIL TARGET C. The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS 70. 5 In Group 1‐6, propofol will be administered first to get a BIS of 50. Next remifentanil will be added and the propofol value will be altered such that BIS remains 50.
- Primary outcomePain Response Index (continuous measurement allowing assessment).
- Secondary outcomeCardiovascular parameters (HR, BP, PPG wave amplitude and non‐invasive CO measured at 30 s intervals from the Nexfin® device) Occurrence of purposeful movement of the patient. BIS values.
- TimepointsMeasurements will be performed just prior to 1) laryngoscopy (during and the 3‐min following) and 2) intubation. The same will be done for insertion of the 3) gastric tube (if applicable), 4) bladder catheter (if applicable) and 5) skin incision.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. C.H. Martini
- CONTACT for SCIENTIFIC QUERIESDrs. C.H. Martini
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsTreister R et al. Differentiating between heat pain intensities: The combined effect of multiple autonomic parameters. Pain. 2012 May 28. 2. Edry R et al. Non‐Linear multi‐parameter approach for evaluation of nociception level during general anesthesia, Proc Conf American Soc of Anes Conf, Oct 2012. 3. Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68.
- Brief summaryDespite various efforts there is still the need for adequate monitoring of pain and nociception during anesthesia. In previous studies we measured pain responses during anesthesia based on single end‐points, eg heart rate, blood pressure and pulse transit time. None of these parameters provided sufficient information regarding nociception. We therefore want to further investigate this matter using a composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the magnitude of the autonomic response to painful stimuli. The NoL combines information from several physiological parameters, which represent different autonomic pathways. This is a multi‐parameter approach empowered with state‐of‐the‐art signal processing and machine learning techniques. The NoL has been shown to have strong association with intensity of the pain stimuli (see publications).
- Main changes (audit trail)
- RECORD15-jan-2014 - 11-apr-2014


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