The Effect of Desflurane Versus Sevoflurane on Postoperative Recovery

NCT05331027 | Completed Phase 4 DMC

• 1 other identifier: RAPID_01
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Recovery; Postoperative Delirium; Difference in Pharmakokinetics of Volatile Anesthetics

Keywords

Minor- to moderate-risk noncardiac surgery; Desflurane; Sevoflurane; Postoperative recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Secondary Outcome 1: Number of liters of supplemental oxygen administered in PACU for SpO2 ≥ 93%

  Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.

• Secondary Outcome 2: Postoperative cerebral oxygen saturation

  Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.

• Secondary Outcome 3: Postoperative bispectral index values

  Until reaching 12 points of the modified Aldrete score for a maximum of 90 minutes after surgery and reaching PACU.

• Secondary Outcome 4: Ready for Hospital Discharge Scale Scores

  For the first three postoperative days

Other Outcomes (9)

• Tertiary Outcome 1: NT-proBNP

  Within the first two postoperative days

• Tertiary Outcome 2: Troponin T

  Within the first two postoperative days

• Tertiary Outcome 3: Copeptin

  Within the first two postoperative days

Study Arms (2)

Desflurane Group

EXPERIMENTAL

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.

Drug: Desflurane

Sevoflurane Group

ACTIVE COMPARATOR

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.

Drug: Sevoflurane

Interventions

Desflurane DRUG

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.

Desflurane Group

Sevoflurane DRUG

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.

Sevoflurane Group

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1100, Austria

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Desflurane; Sevoflurane

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Christian Reiterer, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)