Clinical trial · Interventional
Comparison of Opioid Consumption During TCI Guided by NOL Index or Standard Care Undergoing Intracranial Tumor Surgery
Comparison of Opioid Consumption During Target Controlled Infusion (TCI) Guided by Nociception Level Index (NOL) or Standard Care Undergoing Intracranial Tumor Surgery, Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this prospective, randomized controlled study, we hypothesized that nociception level index monitoring reduced opioid administration during surgery. The secondary goals are to compare the total dose hypnotic drugs, as well as hemodynamic parameters, and to investigate the relationship between changes in the NOL index and HR change following severe noxious stimuli during effect site TCI of propofol and remifentanil in patients undergoing intracranial tumor surgery who are monitored using either standard monitors or the NOL monitor additionally.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia | — | UNRESOLVED | — |
| Intracranial Neoplasm | Intracranial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Nociceptive Pain | — | UNRESOLVED | — |
| Opioid | — | UNRESOLVED | — |
| Target Controlled Infusion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nociception Leve Indeks | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control group
- description
- standard care group
- type
- ACTIVE_COMPARATOR
- label
- study group
- description
- NOL guided group
- interventionNames
- Device: Nociception Leve Indeks
Primary outcomes (1)
- measure
- comparison of administered remifentanil doses (mcg/kg/min)
- timeFrame
- throughout the operation
- description
- This data will be obtained from the TCI device. Demographic data such as the patient's gender, age, weight, etc. are entered into the TCI device. The TCI device displays the total duration of the operation as hour and the total amount of drug used as microgram. To control for patient weight and duration of surgery, we report the anesthesia drug doses as dose/kg/min of anesthesia time.The remifentanil administration dose is indicated in mcg/kg/min. "kg" is patient's actual body weight. "min" is operating time in minutes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * İntracranial mass surgery * Craniotomy * ASA II-II * elective surgery Exclusion Criteria: * pregnant or suspected of pregnancy * receive antiarrhythmic therapy * autonomic nervous system disease * ASA IV * emergency surgery * patients with difficult airway features * patients receiving chronic pain treatment
References
Publications (14)
- BACKGROUNDGuignard B. Monitoring analgesia. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):161-80. doi: 10.1016/j.bpa.2005.09.002. PMID 16634423
- BACKGROUNDLedowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30. PMID 31047645
- RESULTBen-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. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9. PMID 23835792
- RESULTEdry 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. PMID 27171828
- RESULTFuncke S, Pinnschmidt HO, Brinkmann C, Wesseler S, Beyer B, Fischer M, Nitzschke R. Nociception level-guided opioid administration in radical retropubic prostatectomy: a randomised controlled trial. Br J Anaesth. 2021 Feb;126(2):516-524. doi: 10.1016/j.bja.2020.09.051. Epub 2020 Nov 20. PMID 33228979
- RESULTMa D, Ma J, Chen H, Mu D, Kong H, Yu L. Nociception monitors vs. standard practice for titration of opioid administration in general anesthesia: A meta-analysis of randomized controlled trials. Front Med (Lausanne). 2022 Aug 25;9:963185. doi: 10.3389/fmed.2022.963185. eCollection 2022. PMID 36091708
- RESULTMeijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634. PMID 30829658