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 range

60 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Early Recovery in Elderly Patients trials