Clinical trial NCT05331027: The Effect of Desflurane Versus Sevoflurane on Postoperative Recovery
Official title: The Effect of Desflurane Versus Sevoflurane on Postoperative Recovery in Patients Undergoing Minor- to Moderate-risk Noncardiac Surgery - a Prospective Double-blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Recovery
Postoperative Delirium
Difference in Pharmakokinetics of Volatile Anesthetics
Keywords: Minor- to moderate-risk noncardiac surgery
Desflurane
Sevoflurane
Postoperative recovery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 190
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients over the age of 65 years are at increased risk for developing delirium and cognitive complications in the immediate postoperative period after noncardiac surgeries, resulting in increased morbidity and mortality. Previous small studies have shown beneficial effects of desflurane on postoperative cognitive recovery, which has been explained by the more rapid onset and offset of anesthesia as compared to sevoflurane. However, there are very limited data on the effect of desflurane on postoperative recovery and time until criteria for discharge from post-anesthesia care unit (PACU) are fulfilled in elderly patients undergoing minor-to moderate-risk noncardiac surgery. Therefore, the investigators will test the primary hypothesis that general anesthesia with desflurane significantly reduces the time between discontinuation of volatile anesthetics after the end of surgery and reaching ready for discharge from PACU criteria, which are defined as reaching a modified Aldrete score ≥ 12, as compared to sevoflurane in patients ≥ 65 years of age undergoing minor-to moderate-risk noncardiac surgery.

Detailed description: Background: Patients over the age of 65 years are at increased risk for developing delirium and cognitive complications in the immediate postoperative period after noncardiac surgeries, resulting in increased morbidity and mortality. Previous small studies have shown beneficial effects of desflurane on postoperative cognitive recovery, which has been explained by the more rapid onset and offset of anesthesia as compared to sevoflurane. However, there are very limited data on the effect of desflurane on postoperative recovery and time until criteria for discharge from post-anesthesia care unit (PACU) are fulfilled in elderly patients undergoing minor-to moderate-risk noncardiac surgery. Therefore, the investigators will test the primary hypothesis that general anesthesia with desflurane significantly reduces the time between discontinuation of volatile anesthetics after the end of surgery and reaching ready for discharge from PACU criteria, which are defined as reaching amodified Aldrete score ≥ 12, as compared to sevoflurane in patients ≥ 65 years of age undergoing minor-to moderate-risk noncardiac surgery.

Methods: The investigators will include 190 patients ≥ 65 years of age undergoing minor-to moderate-risk noncardiac surgery in this randomized, double-blinded clinical trial. Patients will be randomly assigned to receive desflurane or sevoflurane throughout surgery for maintenance of anesthesia. The primary outcome will be the time between discontinuation of desflurane until full postoperative recovery assessed via consecutive Aldrete Score assessments in the first 90 minutes after arrival at PACU. Aldrete Score will be assessed upon arrival at PACU and thereafter in five-minute intervals.

Statistics: The primary outcome, the time from discontinuation of volatile anesthetic agent to reaching discharge criteria from PACU assessed via Aldrete Score values,will be compared between both study groups using a Mann-Whitney-U test. Furthermore, the investigators will perform a median regression model for time to Aldrete score ≥ 12 points accounting for group as a factor as well as further covariables e.g. age, gender, weight.

Level of originality: Data regarding the effects of general anesthesia using desflurane in comparison to sevoflurane on postoperative recovery are mainly available from small studies. So far, there is very limited data on postoperative recovery and neurocognitive rehabilitation in elderly patients. However, this patient population is at a higher risk of developing postoperative neurocognitive complications, and could therefore, profit from a more rapid resurgence from anesthesia and postoperative recovery. Moreover, outpatient surgery will be becoming even more important. Therefore, reduction in postoperative PACU stay in combination with a decreased risk to develop postoperative delirium or cognitive dysfunction, might therefore improve outcome in this patient population as well.

Eligibility criteria: Inclusion Criteria:

* ≥ 65 years of age at time of surgery
* Scheduled for elective minor- to moderate-risk noncardiac surgery with expected time of surgery ≤ 2 hours

Exclusion Criteria:

* Patients undergoing emergency surgery
* Patients undergoing bariatric surgery
* History of documented dementia / neurologic disorder
* Language, vision, or hearing impairments that may compromise cognitive assessments
* History of malignant hyperthermia
* History of structural muscle disease

Primary outcomes:
measure: Modified Aldrete Score
timeFrame: Consecutive measurements until reaching 12 points for a maximum of 90 minutes after surgery and reaching PACU.
Secondary outcomes:
measure: Secondary Outcome 1: Number of liters of supplemental oxygen administered in PACU for SpO2 ≥ 93%
timeFrame: Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.
measure: Secondary Outcome 2: Postoperative cerebral oxygen saturation
timeFrame: Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.
measure: Secondary Outcome 3: Postoperative bispectral index values
timeFrame: Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.
measure: Secondary Outcome 4: Ready for Hospital Discharge Scale Scores
timeFrame: For the first three postoperative days
Other outcomes:
measure: Tertiary Outcome 1: NT-proBNP
timeFrame: Within the first two postoperative days
measure: Tertiary Outcome 2: Troponin T
timeFrame: Within the first two postoperative days
measure: Tertiary Outcome 3: Copeptin
timeFrame: Within the first two postoperative days
measure: Tertiary Outcome 4: Interleukin-6
timeFrame: Within the first two postoperative days
measure: Tertiary Outcome 5: Procalcitonin
timeFrame: Within the first two postoperative days
measure: Tertiary Outcome 6: CRP
timeFrame: Within the first two postoperative days
measure: Tertiary Outcome 7: S100-B
timeFrame: Within the first two postoperative days
measure: Exploratory Outcome 8: Delirium
timeFrame: For the first three postoperative days
measure: Exploratory Outcome 9: Postoperative cognitive dysfunction
timeFrame: 30 days after surgery
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Christian Reiterer, MD
role: PRINCIPAL_INVESTIGATOR
References: