The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium

NCT05990790 | Recruiting Phase 4 DMC

• 1 other identifier: RAPIDII_01
• Study Type: interventional
• Target: 1,332
• Locations: 1 country
• Sites: 2

Brief Summary

Patients over the age of 65 years are at increased risk for developing delirium after noncardiac surgeries, resulting in increased morbidity and mortality. The prevention of postoperative delirium has been classified as a public health priority. However, so far data regarding possible intraoperative interventions to reduce the incidence of postoperative delirium is very scarce. Due to the more rapid wash-in and wash-out times of desflurane as compared to sevoflurane or propofol it seems reasonable that desflurane might be beneficial for the prevention of postoperative delirium. Therefore, we evaluate the effect of maintenance of anesthesia using desflurane, sevoflurane or propofol on postoperative delirium in elderly patients undergoing moderate- to high-risk major noncardiac surgery.

Conditions

Postoperative Delirium; Major Noncardiac Surgery; Postoperative Cognitive Dysfunction

Keywords

Propofol; Sevoflurane; Desflurane

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial five postoperative days while the patients remain hospitalized according to current recommendations. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium, which will be analyzed dichotomously.

  First five postoperative days

Secondary Outcomes (8)

• Digit Symbol-Substitution-Test for the incidence of postoperative cognitive dysfunction (POCD)

  First five postoperative days

• Trail Making Test (TMT) for the incidence of postoperative cognitive dysfunction (POCD)

  First five postoperative days

• Postoperative need of supplemental oxygen

  During PACU/ICU stay after surgery (max. of first 24 hours after surgery)

• Length of stay in ICU

  First 30 days after surgery

• Incidence of Postoperative nausea and vomiting in the early postoperative period

  First two hours after surgery

Other Outcomes (13)

• Days at home in the first month after surgery

  First 30 days after surgery

• Long-term postoperative cognitive dysfunction

  One year after surgery

• Postoperative IL-6 concentrations (pg/ml)

  First two postoperative days

Study Arms (3)

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±10.

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±10.

Drug: Sevoflurane

Propofol Group

ACTIVE COMPARATOR

After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of propofol with an intraoperative goal of bispectral index (BIS) 50±10.

Drug: Propofol

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±10.

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±10.

Sevoflurane Group

Propofol DRUG

After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of propofol with an intraoperative goal of bispectral index (BIS) 50±10.

Propofol Group

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent
• ≥65 years of age
• Scheduled for elective major noncardiac surgery with estimated time of surgery ≥ 2 hours

You may not qualify if:

• Patients undergoing emergency surgery
• BMI \> 45 kg/m\^2
• History of diagnosed dementia
• Language, vision, or hearing impairments that may compromise cognitive assessments
• History of malignant hyperthermia
• History of structural muscle disease
• History of organ transplantation (kidney, liver, lung, heart)
• Patients undergoing hyperthermic intraperitoneal chemotherapy
• ICU patients undergoing surgery

Sponsors & Collaborators

• Medical University of Vienna: lead
• Medical University Innsbruck: collaborator

Study Sites (2)

Medical University of Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (1)

• Taschner A, Fleischmann E, Kabon B, Sinner B, Eckhardt C, Horvath K, Adamowitsch N, Hantakova N, Hochreiter B, Zotti O, Fraunschiel M, Graf A, Reiterer C; RAPID II Trial investigators. Effect of desflurane, sevoflurane or propofol on the incidence of postoperative delirium in older adults undergoing moderate- to high-risk major non-cardiac surgery: study protocol for a prospective, randomised, observer-blinded, clinical trial (RAPID-II trial). BMJ Open. 2024 Nov 27;14(11):e092611. doi: 10.1136/bmjopen-2024-092611.

  PMID: 39609026 DERIVED

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Interventions

Desflurane; Sevoflurane; Propofol

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; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Christian Reiterer, Prof. MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Taschner, MD

CONTACT

0043 1 40400; alexander.taschner@meduniwien.ac.at

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: July 17, 2023
• First Posted: August 14, 2023
• Study Start: September 3, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)