Sevoflurane versus PRopofol combined with Remifentanil anesthesia Impact on postoperative Neurologic function in supratentorial Gliomas (SPRING): protocol for a randomized controlled trial
Open Access
- 19 May 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in BMC Anesthesiology
- Vol. 20 (1), 1-11
- https://doi.org/10.1186/s12871-020-01035-5
Abstract
Patients with intracranial tumors are more sensitive to anesthetics than the general population and are therefore more susceptible to postoperative neurologic and neurocognitive dysfunction. Sevoflurane or propofol combined with remifentanil are widely used general anesthetic regimens for craniotomy, with neither regimen shown to be superior to the other in terms of neuroprotective efficacy and anesthesia quality. There is no evidence regarding the variable effects on postoperative neurologic and neurocognitive functional outcome under these two general anesthetic regimens. This trial will compare inhalational sevoflurane or intravenous propofol combined with remifentanil anesthesia in patients with supratentorial gliomas and test the hypothesis that postoperative neurologic function is equally affected between the two regimens. This is a prospective, single-center, randomized parallel arm equivalent clinical trial, which is approved by China Ethics Committee of Registering Clinical Trials (ChiECRCT-20,160,051). Patients with supratentorial gliomas diagnosed by magnetic resonance imaging will be eligible for the trial. Written informed consent will be obtained before randomly assigning each subject to either the sevoflurane-remifentanil or propofol-remifentanil group for anesthesia maintenance to achieve an equal-desired depth of anesthesia. Intraoperative intervention and monitoring will follow a standard anesthetic management protocol. All of the physiological parameters and other medications administered during the intervention will be recorded. The primary outcome will be neurologic function change assessed by National Institute of Health Stroke Scale (NIHSS) within 4 h after general anesthesia when observer’s assessment of alertness/sedation (OAA/S) reaches 4. Secondary outcomes will include NIHSS and modified NIHSS change 1 and 2 days after general anesthesia, hemodynamic stability, intraoperative brain relaxation, quality of anesthesia emergence, quality of anesthesia recovery, postoperative cognitive function, postoperative pain, postoperative neurologic complications, as well as perioperative medical expense. This randomized equivalency trial will primarily compare the impacts of sevoflurane-remifentanil and propofol-remifentanil anesthesia on short-term postoperative neurologic function in patients with supratentorial gliomas undergoing craniotomy. The exclusion criteria are strict to ensure that the groups are comparable in all aspects. Repeated and routine neurologic evaluations after operation are always important to evaluate neurosurgical patients’ recovery and any newly presenting complications. The results of this trial would help specifically to interpret anesthetic residual effects on postoperative outcomes, and perhaps would help the anesthesiologist to select the optimal anesthetic regimen to minimize its impact on neurologic function in this specific patient population. The study was registered and approved by the Chinese Clinical Trial Registry (Chinese Clinical Trial Registry, ChiCTR-IOR-16009177). Principle investigator: Nan Lin (email address: linnan127@gmail.com) and Ruquan Han (email address: hanrq666@aliyun.com) Date of Registration: September 8th, 2016. Country of recruitment: China.Keywords
Funding Information
- Beijing Municipal Administration of Hospitals' Youth Program (QML20160503)
- National Natural Science Foundation of China (81701038)
- Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support (ZYLX201708)
This publication has 27 references indexed in Scilit:
- A multicentre, randomised, open-label, controlled trial evaluating equivalence of inhalational and intravenous anaesthesia during elective craniotomyEuropean Journal of Anaesthesiology, 2012
- Production and Validation of Putonghua- and Cantonese-Chinese Language National Institutes of Health Stroke Scale Training and Certification VideosInternational Journal of Stroke, 2010
- Relationship Between Regional Cerebral Blood Flow and Electrocorticographic Activities Under Sevoflurane and Isoflurane AnesthesiaJournal of Clinical Neurophysiology, 2010
- The Modified National Institutes of Health Stroke Scale: its Time has ComeInternational Journal of Stroke, 2009
- Inhalational or intravenous anesthetics for craniotomies? Pro inhalationalCurrent Opinion in Anaesthesiology, 2006
- The Effects of Stimulation Pattern and Sevoflurane Concentration on Intraoperative Motor-Evoked PotentialsAnesthesia & Analgesia, 2006
- Modified National Institutes of Health Stroke Scale for Use in Stroke Clinical TrialsStroke, 2002
- Cerebral Hemodynamic Response to the Introduction of Desflurane: A Comparison with SevofluraneAnesthesia & Analgesia, 2000
- Dynamic Cerebral Autoregulation During Sevoflurane AnesthesiaAnesthesia & Analgesia, 1999
- Reliability of the National Institutes of Health Stroke ScaleStroke, 1997