The Effect of Desflurane Versus Sevoflurane on Postoperative Recovery

Postoperative Delirium Clinical Trial

— RAPID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05331027
• Other study ID #: RAPID_01
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Delirium
• Postoperative Delirium
• Postoperative Recovery

Intervention

Drug:
• Desflurane
After induction of anesthesia maintenance of anesthesia will be performed using goal-directed administration of desflurane with an intraoperative goal of bispectral index (BIS) 50±5.
• Sevoflurane
After induction of anesthesia maintenance of anesthesia will be performed using goal-directed administration of sevoflurane with an intraoperative goal of bispectral index (BIS) 50±5.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tertiary Outcome 1: NT-proBNP	Maximum concentrations of NT-proBNP	Within the first two postoperative days
Other	Tertiary Outcome 2: Troponin T	Maximum concentrations of Troponin T	Within the first two postoperative days
Other	Tertiary Outcome 3: Copeptin	Maximum concentrations of Copeptin	Within the first two postoperative days
Other	Tertiary Outcome 4: Interleukin-6	Maximum concentrations of Interleukin-6	Within the first two postoperative days
Other	Tertiary Outcome 5: Procalcitonin	Maximum concentrations of Procalcitonin	Within the first two postoperative days
Other	Tertiary Outcome 6: CRP	Maximum concentrations of CRP	Within the first two postoperative days
Other	Tertiary Outcome 7: S100-B	Maximum concentration of S-100B	Within the first two postoperative days
Other	Exploratory Outcome 8: Delirium	3D-CAM questionnaires for the evaluation of postoperative delirium. Patients can achieve 0-22 points in the 3D-CAM questionnaire. Higher scores indicate confusion, lower scores indicate no confusion.	For the first three postoperative days
Other	Exploratory Outcome 9: Postoperative cognitive dysfunction	Montreal cognitive assessments for the evaluation of long-term postoperative cognitive dysfunction. Patients can achieve 0-22 points in the Montreal cognitive assessment. A reduction of 2 points from baseline indicates postoperative cognitive dysfunction.	30 days after surgery
Primary	Modified Aldrete Score	A score to assess readiness of discharge from postanesthesia care unit (PACU). Patients can achieve 0-14 points in the modified Aldrete Score. A modified Aldrete Score > 12 points signals that criteria for discharge from PACU have been fulfilled, a modified Aldrete Score < 12 points signals that patients should stay in PACU.	Consecutive measurements until reaching 12 points for a maximum of 90 minutes after surgery and reaching PACU.
Secondary	Secondary Outcome 1: Number of liters of supplemental oxygen administered in PACU for SpO2 = 93%	Postoperative need for administration of supplemental oxygen to maintain a SpO2 of = 93% during PACU stay	Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.
Secondary	Secondary Outcome 2: Postoperative cerebral oxygen saturation	Postoperative non-invasive near-infrared spectroscopy for measurement of cerebral oxygenation	Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.
Secondary	Secondary Outcome 3: Postoperative bispectral index values	Postoperative continuous measurement of bispectral index for detection of postoperative aftereffects of anesthesia on awareness	Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.
Secondary	Secondary Outcome 4: Ready for Hospital Discharge Scale Scores	A score to evaluate patients' subjective readiness for hospital discharge. Patients can achieve 0-80 points in the Ready for Hospital Discharge Scale. Higher scores mean that patients are ready for hospital discharge, lower scores mean that patients are not ready for hospital discharge.	For the first three postoperative days