Effects of Sevoflurane vs Desflurane on Early Recovery and Cognitive Function in Elderly Patients Undergoing Scheduled Non-Cardiac Surgery

NCT07289945 | Completed Phase 3

• 1 other identifier: FWA 00032748 IORG0011243
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to compare the effects of desflurane versus sevoflurane on early postoperative recovery and cognitive function in elderly patients (aged 60 years and older, ASA I-III) undergoing elective non-cardiac surgery under general anesthesia. The main questions this study aims to answer are: 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.

Conditions

Early Recovery in Elderly Patients; Cognitive Function

Keywords

desflurane; sevoflurane; elderly; general anesthesia; recovery; cognition

Outcome Measures

Primary Outcomes (3)

• Time to eye opening

  Time from discontinuation to the volatile agent to eye opening

  within 3 to 24 minutes after discontinuiation of the volatile agent

• Time to obey verbal command

  Time from discontinuation of the volatile agent to obeying verbal command

  within 5 to 40 minutes after discontinuation of the volatile agent

• Time to extubation

  Time from discontinuation of the volatile agent to extubation

  within 6 to 30 minutes after disontinuation of the volatile agent

Secondary Outcomes (3)

• Time to reach a Modified Aldrete Score 9 or greater

  within 10 to 48 minutes after discontinuation of the volatile agent

• Time to discharge from the recovery room

  within 12 to 53 minutes after discontinuation of the volatile agent

• Time to reach a SOMCT 20 or higher

  within 15 to 55 minutes from discontinuation of the volatile agent

Study Arms (2)

sevoflurane group

ACTIVE COMPARATOR

Participants receive Sevoflurane for anesthesia maintenance with a Fresh Gaz Flow of less than 1 L/min.

Drug: Sevoflurane

Desflurane group

ACTIVE COMPARATOR

Participants receive Desflurane for anesthesia maintenance with a Fresh Gaz Flow of less than 0.5 L/min.

Drug: Desflurane

Interventions

Sevoflurane DRUG

Sevoflurane used for anesthesia maintenance with a MAC of 2-3% and FGF of less than 1 L/min.

sevoflurane group

Desflurane DRUG

Desflurane used for anesthesia maintenance with a MAC of 4-6% and FGF of less than 0.5 L/min.

Desflurane group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elderly patients whose ages are superior to 60 years of age \[1\].
• 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.

You may not qualify if:

• We excluded from our study patients who presented with perioperative complication or instability requiring ICU transfer due to extubation failure.

Sponsors & Collaborators

• Hopital Charles Nicolle: lead

Study Sites (1)

Hospital of Charles Nicolle, Tunis, Tunis 1006

Tunis, Tunis Governorate, 1006, Tunisia

Location

Related Publications (11)

• 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.

  PMID: 29614656 BACKGROUND

• 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.

  PMID: 6846631 BACKGROUND

• 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.

  PMID: 21431051 BACKGROUND

• 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.

  PMID: 23493107 BACKGROUND

• 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.

  PMID: 34103741 BACKGROUND

• 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.

  PMID: 17621601 BACKGROUND

• 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.

  PMID: 19608808 BACKGROUND

• 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.

  PMID: 31057241 BACKGROUND

• 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.

  PMID: 30940302 BACKGROUND

• 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.

  PMID: 20233751 BACKGROUND

• 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.

  PMID: 36609226 BACKGROUND

Related Links

• 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

MeSH Terms

Interventions

Sevoflurane; Desflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology and Intensive Care Department at Charles Nicolle Hospital in Tunis

Model Details: This prospective randomized single-blind trial compares desflurane versus sevoflurane for assessing early postoperative recovery and cognitive function in elderly patients undergoing elective non-cardiac surgery. Primary objectives: evaluate the time from discontinuation of the volatile agent to eye opening, response to verbal commands, and extubation. Secondary objectives include the time required to achieve a modified Aldrete Score (MAS) ≥9, post-anesthesia care unit (PACU) discharge time, and the interval to reach an SOMCT score ≥20. Inclusion criteria: patients aged over 60 years, ASA physical status I-III, scheduled for elective non-cardiac surgery under general anesthesia. Exclusion criteria: pre-existing cognitive impairment (baseline SOMCT \<20), severe hepatic or renal failure, anticipated difficult airway, emergency surgery, or refusal to participate. A total of 81 patients were randomized into two groups to receive either desflurane or sevoflurane for anesthesia maintenance.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: September 15, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

TU (1)