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Early Recovery in Elderly PatientsPhase 3NCT07289945

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

A Phase 3 study testing Sevoflurane and Desflurane in people with Early Recovery in Elderly Patients and Cognitive Function, run by Hopital Charles Nicolle at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Sevoflurane and Desflurane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteTunisia
Study dates
15 Sep 2024to 15 Apr 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Non-inclusion criteria:
  • 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).
Show all 13Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • Hospital of Charles Nicolle, Tunis, Tunis 1006

    Tunis, Tunis Governorate, 1006

Other trials in Tunisia

About this study

Official title: A COMPARATIVE STUDY OF DESFLURANE VERSUS SEVOFLURANE IN ELDERLY PATIENTS: EFFECT ON EARLY RECOVERY

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.

Read more

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.

Read the detailed description

Delayed emergence from anesthesia and early postoperative cognitive decline represent important clinical challenges in elderly surgical patients, who commonly exhibit reduced physiological reserve, altered pharmacodynamics, and multiple comorbidities. The combination of age-related organ changes, diminished drug clearance, and increased sensitivity of the central nervous system places this population at heightened risk of prolonged awakening, impaired reflexes, and postoperative disorientation. Volatile anesthetics such as sevoflurane and desflurane are widely used in geriatric anesthesia owing to their low blood/gas solubility and generally favorable recovery profiles, yet their comparative impact on early emergence and cognitive recovery remains insufficiently established. This prospective randomized single-blind trial is therefore designed to compare desflurane with sevoflurane in elderly patients undergoing elective non-cardiac surgery, with the objective of determining whether desflurane's lower blood/gas partition coefficient translates into clinically meaningful improvements in postoperative recovery.

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).

Being tested
Sevoflurane, Desflurane
Keywords
desflurane, sevoflurane, elderly, general anesthesia, recovery, cognition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SevofluraneDrug

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

  • DesfluraneDrug

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

Study groups in NCT07289945
Study groupRoleWhat they receive
sevoflurane groupActive comparatorParticipants receive Sevoflurane for anesthesia maintenance with a Fresh Gaz Flow of less than 1 L/min.
Receives: Drug: Sevoflurane
Desflurane groupActive comparatorParticipants receive Desflurane for anesthesia maintenance with a Fresh Gaz Flow of less than 0.5 L/min.
Receives: Drug: Desflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to eye opening

    Time from discontinuation to the volatile agent to eye opening

    Measured: within 3 to 24 minutes after discontinuiation of the volatile agent

  2. Time to obey verbal command

    Time from discontinuation of the volatile agent to obeying verbal command

    Measured: within 5 to 40 minutes after discontinuation of the volatile agent

  3. Time to extubation

    Time from discontinuation of the volatile agent to extubation

    Measured: within 6 to 30 minutes after disontinuation of the volatile agent

Secondary outcomes (3)
  1. Time to reach a Modified Aldrete Score 9 or greater

    Time from discontinuation of the volatile agent to reaching a Modified Aldrete Score 9 or greater

    Measured: within 10 to 48 minutes after discontinuation of the volatile agent

  2. Time to discharge from the recovery room

    Time from discontinuation of the volatile agent to discharge from the recovery room

    Measured: within 12 to 53 minutes after discontinuation of the volatile agent

  3. Time to reach a SOMCT 20 or higher

    Time from discontinuation of the volatile agent to reaching a SOMCT 20 or higher

    Measured: within 15 to 55 minutes from discontinuation of the volatile agent

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start15 Sep 2024
  3. Primary completion15 Apr 2025
  4. Study completion15 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07289945
Sponsor's protocol ID
FWA 00032748 IORG0011243
Status last verified
Dec 2025
First submitted
4 Dec 2025
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29614656
  • 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.

    PubMed 6846631
  • 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.

    PubMed 21431051
  • 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.

    PubMed 23493107
  • 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.

    PubMed 34103741
  • 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.

    PubMed 17621601
  • 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.

    PubMed 19608808
  • 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.

    PubMed 31057241
  • 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.

    PubMed 30940302
  • 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.

    PubMed 20233751
  • 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.

    PubMed 36609226

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sevoflurane and Desflurane in people with Early Recovery in Elderly Patients and Cognitive Function, run by Hopital Charles Nicolle at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to eye opening (time frame: within 3 to 24 minutes after discontinuiation of the volatile agent). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07289945, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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