Hospital of Charles Nicolle, Tunis, Tunis 1006
Tunis, Tunis Governorate, 1006, Tunisia
NCT Number: NCT07289945
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.
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Notify Me60 year and older
All sexes
Interventional
Phase 3
Tunis, Tunis Governorate, 1006, Tunisia
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion criteria:
Exclusion criteria
Sevoflurane used for anesthesia maintenance with a MAC of 2-3% and FGF of less than 1 L/min.
Desflurane used for anesthesia maintenance with a MAC of 4-6% and FGF of less than 0.5 L/min.
Time frame: within 3 to 24 minutes after discontinuiation of the volatile agent
Time from discontinuation to the volatile agent to eye opening
Time frame: within 5 to 40 minutes after discontinuation of the volatile agent
Time from discontinuation of the volatile agent to obeying verbal command
Time frame: within 6 to 30 minutes after disontinuation of the volatile agent
Time from discontinuation of the volatile agent to extubation
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
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
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
Hopital Charles Nicolle
Other
A COMPARATIVE STUDY OF DESFLURANE VERSUS SEVOFLURANE IN ELDERLY PATIENTS: EFFECT ON EARLY RECOVERY
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