CompletedPhase 3

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

Tunisia81 participantsStarted 2024-09-15

Plain-language 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.

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Time to eye opening

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

Time to obey verbal command

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

Time to extubation

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

Trial details

NCT IDNCT07289945

SponsorHopital Charles Nicolle

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-15