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

December 4, 2025 updated by: jebri alia, Hopital Charles Nicolle

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Tunis Governorate
      • Tunis, Tunis Governorate, Tunisia, 1006
        • Hospital of Charles Nicolle, Tunis, Tunis 1006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).
  • 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sevoflurane group
Participants receive Sevoflurane for anesthesia maintenance with a Fresh Gaz Flow of less than 1 L/min.
Drug: Sevoflurane
Sevoflurane used for anesthesia maintenance with a MAC of 2-3% and FGF of less than 1 L/min.
Active Comparator: Desflurane group
Participants receive Desflurane for anesthesia maintenance with a Fresh Gaz Flow of less than 0.5 L/min.
Drug: Desflurane
Desflurane used for anesthesia maintenance with a MAC of 4-6% and FGF of less than 0.5 L/min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to eye opening
Time Frame: within 3 to 24 minutes after discontinuiation of the volatile agent
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 Frame: within 5 to 40 minutes after discontinuation of the volatile agent
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 Frame: within 6 to 30 minutes after disontinuation of the volatile agent
Time from discontinuation of the volatile agent to extubation
within 6 to 30 minutes after disontinuation of the volatile agent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach a Modified Aldrete Score 9 or greater
Time Frame: within 10 to 48 minutes after discontinuation of the volatile agent
Time from discontinuation of the volatile agent to reaching 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
Time Frame: within 12 to 53 minutes after discontinuation of the volatile agent
Time from discontinuation of the volatile agent 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
Time Frame: within 15 to 55 minutes from discontinuation of the volatile agent
Time from discontinuation of the volatile agent to reaching a SOMCT 20 or higher
within 15 to 55 minutes from discontinuation of the volatile agent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Charles Nicolle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2024

Primary Completion (Actual)

April 15, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWA 00032748 IORG0011243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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