The Effect of Desflurane Versus Sevoflurane on Postoperative Recovery (RAPID)
Primary Purpose
Postoperative Recovery, Postoperative Delirium, Difference in Pharmakokinetics of Volatile Anesthetics
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Desflurane
Sevoflurane
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Recovery focused on measuring Minor- to moderate-risk noncardiac surgery, Desflurane, Sevoflurane, Postoperative recovery
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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Desflurane Group
Sevoflurane Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Secondary Outcome 2: Postoperative cerebral oxygen saturation
Postoperative non-invasive near-infrared spectroscopy for measurement of cerebral oxygenation
Secondary Outcome 3: Postoperative bispectral index values
Postoperative continuous measurement of bispectral index for detection of postoperative aftereffects of anesthesia on awareness
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.
Full Information
NCT ID
NCT05331027
First Posted
April 8, 2022
Last Updated
June 14, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT05331027
Brief Title
The Effect of Desflurane Versus Sevoflurane on Postoperative Recovery
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Recovery, Postoperative Delirium, Difference in Pharmakokinetics of Volatile Anesthetics
Keywords
Minor- to moderate-risk noncardiac surgery, Desflurane, Sevoflurane, Postoperative recovery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desflurane Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sevoflurane Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Aldrete Score
Description
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.
Time Frame
Consecutive measurements until reaching 12 points for a maximum of 90 minutes after surgery and reaching PACU.
Secondary Outcome Measure Information:
Title
Secondary Outcome 1: Number of liters of supplemental oxygen administered in PACU for SpO2 ≥ 93%
Description
Postoperative need for administration of supplemental oxygen to maintain a SpO2 of ≥ 93% during PACU stay
Time Frame
Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.
Title
Secondary Outcome 2: Postoperative cerebral oxygen saturation
Description
Postoperative non-invasive near-infrared spectroscopy for measurement of cerebral oxygenation
Time Frame
Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.
Title
Secondary Outcome 3: Postoperative bispectral index values
Description
Postoperative continuous measurement of bispectral index for detection of postoperative aftereffects of anesthesia on awareness
Time Frame
Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.
Title
Secondary Outcome 4: Ready for Hospital Discharge Scale Scores
Description
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.
Time Frame
For the first three postoperative days
Other Pre-specified Outcome Measures:
Title
Tertiary Outcome 1: NT-proBNP
Description
Maximum concentrations of NT-proBNP
Time Frame
Within the first two postoperative days
Title
Tertiary Outcome 2: Troponin T
Description
Maximum concentrations of Troponin T
Time Frame
Within the first two postoperative days
Title
Tertiary Outcome 3: Copeptin
Description
Maximum concentrations of Copeptin
Time Frame
Within the first two postoperative days
Title
Tertiary Outcome 4: Interleukin-6
Description
Maximum concentrations of Interleukin-6
Time Frame
Within the first two postoperative days
Title
Tertiary Outcome 5: Procalcitonin
Description
Maximum concentrations of Procalcitonin
Time Frame
Within the first two postoperative days
Title
Tertiary Outcome 6: CRP
Description
Maximum concentrations of CRP
Time Frame
Within the first two postoperative days
Title
Tertiary Outcome 7: S100-B
Description
Maximum concentration of S-100B
Time Frame
Within the first two postoperative days
Title
Exploratory Outcome 8: Delirium
Description
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.
Time Frame
For the first three postoperative days
Title
Exploratory Outcome 9: Postoperative cognitive dysfunction
Description
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.
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Reiterer, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1100
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not share any individual participant data
Learn more about this trial
The Effect of Desflurane Versus Sevoflurane on Postoperative Recovery
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