Effects of Sevoflurane vs Desflurane on Early Recovery and Cognitive Function in Elderly Patients Undergoing Scheduled Non-Cardiac Surgery
NCT ID: NCT07289945
Last Updated: 2025-12-17
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
81 participants
INTERVENTIONAL
2024-09-15
2025-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Which anesthetic agent allows faster emergence from anesthesia (eye opening, response to commands, extubation)? Does desflurane lead to earlier cognitive recovery as measured by the Short Orientation Memory Concentration Test (SOMCT)? Does the choice of volatile anesthetic influence the time required to achieve a modified Aldrete score (MAS) ≥ 9 and PACU discharge readiness? Researchers compared the desflurane group to the sevoflurane group to determine whether desflurane provides a superior recovery profile and minimizes delayed emergence in elderly surgical patients.
Participants will:
Be randomly assigned to receive either desflurane or sevoflurane for maintenance of general anesthesia.
Undergo standardized induction with fentanyl, propofol, and cisatracurium, along with uniform ventilatory and monitoring protocols.
Have emergence parameters recorded immediately after discontinuation of the inhaled agent (eye opening, command following, extubation).
Be evaluated in the post-anesthesia care unit using the modified Aldrete Score (MAS) and SOMCT, with predefined thresholds for recovery (MAS ≥ 9, SOMCT ≥ 20). This study aims to determine whether desflurane-due to its lower blood/gas partition coefficient-offers measurable clinical benefits in terms of rapid awakening, cognitive recovery, and overall early postoperative recovery in the geriatric population.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions Conditions: Postoperative Delayed Emergence and Early Cognitive Decline in Elderly Surgical Patients Keywords: general anesthesia, elderly, desflurane; sevoflurane; recovery, cognition. Study Design Study Type: Interventional. The perioperative protocol begins with standard patient preparation, including verification of the pre-anesthesia checklist and initiation of monitoring with ECG, pulse oximetry, non-invasive blood pressure, and capnography. Three baseline hemodynamic readings are recorded to establish reference values. Two peripheral IV lines (18-20G) are inserted for fluids and medication administration. Patients underwent a baseline Short Orientation Memory Concentration Test (SOMCT). Anesthesia induction is standardized with Fentanyl: 2 µg/kg, Propofol: titrated to loss of consciousness, Cisatracurium: 0.15 mg/kg to facilitate intubation. Endotracheal intubation is confirmed by capnography. Patients are randomized into two groups:
Group D - Desflurane, Group S - Sevoflurane, maintenance protocol under controlled ventilation targeting ETCO₂ between 30 and 40 mmHg. Volatile agents are discontinued at the end of surgery, and emergence parameters-including time to eye opening, response to verbal commands, and extubation-were recorded by a blinded observer. In the post-anesthesia care unit, recovery is assessed using the modified Aldrete Score (MAS) until ≥9 and SOMCT until ≥20, and discharge times are documented. Hemodynamic, respiratory, and anesthetic variables are continuously monitored throughout the procedure. Statistical Analysis: Data entry and analysis will be performed using SPSS software (version 25.0). Descriptive Analysis: Normally distributed continuous quantitative variables will be summarized as mean ± standard deviation. Non-normally distributed continuous variables will be reported as median and interquartile range \[IQR: 25%-75%\]. Categorical variables will be presented as absolute frequencies (n) and relative frequencies (%). Analytical Analysis: Associations between two categorical variables will be assessed using Pearson's chi-square test when conditions are met; otherwise, Fisher's exact test will be applied. For comparisons between a categorical and a normally distributed quantitative variable, Student's t-test will be used, while the Mann-Whitney U test will be employed for non-parametric data. A significance level of p \< 0.05 will be considered statistically significant. In multivariate analysis, risk estimates will be expressed as odds ratios (OR) with 95% confidence intervals (95% CI).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
sevoflurane group
Participants receive Sevoflurane for anesthesia maintenance with a Fresh Gaz Flow of less than 1 L/min.
Sevoflurane
Sevoflurane used for anesthesia maintenance with a MAC of 2-3% and FGF of less than 1 L/min.
Desflurane group
Participants receive Desflurane for anesthesia maintenance with a Fresh Gaz Flow of less than 0.5 L/min.
Desflurane
Desflurane used for anesthesia maintenance with a MAC of 4-6% and FGF of less than 0.5 L/min.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sevoflurane
Sevoflurane used for anesthesia maintenance with a MAC of 2-3% and FGF of less than 1 L/min.
Desflurane
Desflurane used for anesthesia maintenance with a MAC of 4-6% and FGF of less than 0.5 L/min.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with an American Society of Anesthesiologists Classification (ASA) I, II or III stable (Annex 1).
* Patients undergoing elective non-cardiac surgery under general anesthesia with tracheal intubation.
* Patients having declined to participate in the study protocol.
* Patients with a contraindication for minimal flow anesthesia such as hyperthermia, smoke intoxication and ketoacidosis metabolic condition (for example, anorexia nervosa).
* Patients with history of malignant hyperthermia.
* Patients with Psychotic disorders.
* Patients with substance abuse.
* Patients with severe obstructive or restrictive pulmonary disease.
* Patients with hepatic disease.
* Patients with end stage renal disease.
* Patients with history of allergy to study drugs.
Exclusion Criteria
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hopital Charles Nicolle
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
jebri alia
Head of Anesthesiology and Intensive Care Department at Charles Nicolle Hospital in Tunis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital of Charles Nicolle, Tunis, Tunis 1006
Tunis, Tunis Governorate, Tunisia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kim CT, Myung W, Lewis M, Lee H, Kim SE, Lee K, Lee C, Choi J, Kim H, Carroll BJ, Kim DK. Exposure to General Anesthesia and Risk of Dementia: A Nationwide Population-Based Cohort Study. J Alzheimers Dis. 2018;63(1):395-405. doi: 10.3233/JAD-170951.
Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H. Validation of a short Orientation-Memory-Concentration Test of cognitive impairment. Am J Psychiatry. 1983 Jun;140(6):734-9. doi: 10.1176/ajp.140.6.734.
Jindal R, Kumra VP, Narani KK, Sood J. Comparison of maintenance and emergence characteristics after desflurane or sevoflurane in outpatient anaesthesia. Indian J Anaesth. 2011 Jan;55(1):36-42. doi: 10.4103/0019-5049.76604.
Kaur A, Jain AK, Sehgal R, Sood J. Hemodynamics and early recovery characteristics of desflurane versus sevoflurane in bariatric surgery. J Anaesthesiol Clin Pharmacol. 2013 Jan;29(1):36-40. doi: 10.4103/0970-9185.105792.
Saha M, Saxena KN, Wadhwa B. Comparative study of recovery of airway reflexes and cognitive function following sevoflurane versus desflurane anaesthesia. Indian J Anaesth. 2021 Apr;65(4):282-288. doi: 10.4103/ija.IJA_1219_20. Epub 2021 Apr 15.
La Colla L, Albertin A, La Colla G, Mangano A. Faster wash-out and recovery for desflurane vs sevoflurane in morbidly obese patients when no premedication is used. Br J Anaesth. 2007 Sep;99(3):353-8. doi: 10.1093/bja/aem197. Epub 2007 Jul 9.
White PF, Tang J, Wender RH, Yumul R, Stokes OJ, Sloninsky A, Naruse R, Kariger R, Norel E, Mandel S, Webb T, Zaentz A. Desflurane versus sevoflurane for maintenance of outpatient anesthesia: the effect on early versus late recovery and perioperative coughing. Anesth Analg. 2009 Aug;109(2):387-93. doi: 10.1213/ane.0b013e3181adc21a.
Gangakhedkar GR, Monteiro JN. A prospective randomized double-blind study to compare the early recovery profiles of desflurane and sevoflurane in patients undergoing laparoscopic cholecystectomy. J Anaesthesiol Clin Pharmacol. 2019 Jan-Mar;35(1):53-57. doi: 10.4103/joacp.JOACP_375_17.
Wang C, Li L, Xu H, Lv H, Zhang H. Effect of desflurane-remifentanil or sevoflurane-remifentanil on early recovery in elderly patients: a meta-analysis of randomized controlled trials. Pharmazie. 2019 Apr 1;74(4):201-205. doi: 10.1691/ph.2019.8935.
Lockwood G. Theoretical context-sensitive elimination times for inhalation anaesthetics. Br J Anaesth. 2010 May;104(5):648-55. doi: 10.1093/bja/aeq051. Epub 2010 Mar 16.
Wagner S, Breitkopf M, Ahrens E, Ma H, Kuester O, Thomas C, von Arnim CAF, Walther A. Cognitive function in older patients and their stress challenge using different anesthesia regimes: a single center observational study. BMC Anesthesiol. 2023 Jan 6;23(1):6. doi: 10.1186/s12871-022-01960-7.
Related Links
Access external resources that provide additional context or updates about the study.
World Health Organization. World Health Statistics 2016: Monitoring Health for the Sustainable Development Goals
National Library of Medicine. Sevoflurane \[Online\]. Bethesda (MD): National Center for Biotechnology Information
Effect of desflurane and sevoflurane on postoperative cognitive dysfunction: A meta-analysis of randomized controlled trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FWA 00032748 IORG0011243
Identifier Type: -
Identifier Source: org_study_id