Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruiting
Participants planned
1,332
Countries
1
Sites
3
Elderly patients undergoing moderate- to high-risk major non cardiac surgery
Our primary aim is to evaluate the effect of maintenance of general anesthesia using desflurane, sevoflurane or propofol on the incidence of postoperative delirium within the first five postoperative days in elderly patients undergoing moderate- to high-risk major noncardiac surgery.
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 19 Jul 2023 → ongoing
- Decision date (initial)
- 2023-06-19
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
Our primary aim is to evaluate the effect of maintenance of general anesthesia using desflurane, sevoflurane or propofol on the incidence of postoperative delirium within the first five postoperative days in elderly patients undergoing moderate- to high-risk major noncardiac surgery.
Secondary objectives 8
- Our secondary aim 1 will be to evaluate the effect of desflurane versus sevoflurane versus propofol on the incidence of postoperative cognitive dysfunction (POCD).
- Our secondary aim 2 will be to evaluate the effect of anesthesia using desflurane versus sevoflurane versus propofol on the incidence of long-term postoperative cognitive dysfunction.
- Our secondary aim 3 will be to evaluate the difference in the incidence of PONV in the early postoperative period between patients, who received desflurane versus sevoflurane versus propofol for maintenance of general anesthesia.
- Our secondary aim 4 will be to evaluate the difference in the incidence of PONV in the late postoperative period between patients, who received desflurane versus sevoflurane versus propofol for maintenance of general anesthesia.
- Our secondary aim 5 will be to evaluate the effect of maintenance of anesthesia using desflurane versus sevoflurane versus propofol on postoperative need for administration of supplemental oxygen for SpO2 ≥93%.
- Our secondary aim 6 will be to evaluate the effect of maintenance of anesthesia using desflurane versus sevoflurane versus propofol on intraoperative duration of mean arterial pressure (MAP) < 65 mmHg and overall amount of intraoperatively administered catecholamines.
- Our secondary aim 7 will be to determine the difference in the length of stay in the intensive care unit between the study groups.
- Our secondary aim 8 will be to determine the difference in the number of days at home in the first month after surgery between the study groups.
Conditions and MedDRA coding
Elderly patients undergoing moderate- to high-risk major non cardiac surgery
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10078610 | Postoperative delirium | 100000004863 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Enrollment Checking for eligibility in the surgical schedule, patients' electronic records and charts. Obtaining informed consent.
|
Not Applicable | None | ||
| 2 | Intervention Patient randomization will be performed shortly before induction of anesthesia (within 1 hour before induction of anesthesia). For randomization we will use the online randomization “Randomizer” (Randomizer, Medical University of Graz, Graz, Austria: https://www.meduniwien.ac.at/randomizer/web/login.php) provided by the ITSC (IT Systems & Communications, Medical University of Vienna, 1090 Vienna, Austria). Randomization will be performed with permutated blocks stratified by study center. Randomization will only be performed by registered persons, who are not involved in postoperative outcome assessments. For log-in, and individual User-ID and password entry are necessary. The ID- number will be a consecutive number of the patient, who will meet the inclusion criteria. Patients will be randomized 1:1:1.
|
Randomised Controlled | Single | [{"id":78142,"code":2,"name":"Investigator"},{"id":78143,"code":1,"name":"Subject"}] | 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±10. 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±10. Propofol: 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. |
| 3 | Short term follow-up Study specific assessments will be performed by blinded study personnel including neurocognitive assessments and blood samples within the first five postoperative days
|
Randomised Controlled | Single | [{"id":78146,"code":1,"name":"Subject"},{"id":78145,"code":2,"name":"Investigator"}] | |
| 4 | Long-term follow-up Long-term study specific follow-ups will be performed 30 days and one year after surgery by blinded study personnel.
|
Randomised Controlled | Single | [{"id":78148,"code":2,"name":"Investigator"},{"id":78149,"code":1,"name":"Subject"}] |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Individual participant data will not be shared.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-000556-11 | 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 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 1. Provide written informed consent
- 2. ≥ 65 years of age
- 3. Scheduled for elective major noncardiac surgery with estimated time of surgery ≥ 2 hours
Exclusion criteria 9
- 1. Patients undergoing emergency surgery
- 2. BMI > 45 kg/m2
- 3. History of diagnosed dementia
- 4. Language, vision, or hearing impairments that may compromise cognitive assessments
- 5. History of malignant hyperthermia
- 6. History of structural muscle disease
- 7. History of organ transplantation (kidney, liver, lung, heart)
- 8. Patients undergoing hyperthermic intraperitoneal chemotherapy
- 9. ICU patients undergoing surgery
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of postoperative delirium within the first five postoperative days between maintenance of anesthesia with desflurane, sevoflurane or propofol in elderly patients undergoing noncardiac surgery
Secondary endpoints 8
- Incidence of postoperative cognitive dysfunction
- Incidence of long-term postoperative cognitive dysfunction
- Incidence of postoperative nausea and vomiting (PONV) within the first two postoperative hours
- Incidence of PONV from two hours after surgery until the fifth postoperative day
- Administration of supplemental oxygen in PACU or ICU for SpO2 ≥ 93%.
- Intraoperative duration of mean arterial pressure <65mmHg and overall amount of intraoperatively administered catecholamines (including phenylephrine, norepinephrine, epinephrine, etilefrine, ephedrine)
- Length of stay in the ICU after surgery until hospital discharge
- Number of days at home within the first 30 postoperative days
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUPRANE - Inhalationsnarkotikum
PRD319829 · Product
- Active substance
- Desflurane
- Pharmaceutical form
- INHALATION VAPOUR, LIQUID
- Route of administration
- INHALATION USE
- Max daily dose
- 15 % (V/V) percent volume/volume
- Max total dose
- 15 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AB07 — DESFLURANE
- Marketing authorisation
- 1-20922
- MA holder
- BAXTER HEALTHCARE GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
Sevorane – Inhalationsnarkotikum
PRD1605242 · Product
- Active substance
- Sevoflurane
- Pharmaceutical form
- INHALATION VAPOUR, LIQUID
- Route of administration
- INHALATION USE
- Max daily dose
- 6 % (V/V) percent volume/volume
- Max total dose
- 6 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AB08 — SEVOFLURANE
- Marketing authorisation
- 1-21565
- MA holder
- ABBVIE GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Propofol „Fresenius" 2 % mit MCT - Emulsion zur Injektion oder Infusion
PRD700466 · Product
- Active substance
- Propofol
- Substance synonyms
- 2,6-Bis(PROPAN-2-YL)PHENOL, DISOPROFOL, 2,6-DIPROPAN-2-YLPHENOL
- Pharmaceutical form
- EMULSION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 12 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 12 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- 1-25831
- MA holder
- FRESENIUS KABI AUSTRIA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Waehringer Guertel 18-20, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Anesthesia, General Intensive Care Medicine and Pain Medicine
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Anesthesia, General Intensive Care Medicine and Pain Medicine
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 1,332 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Medical University Of Vienna
Department of Anesthesia, General Intensive Care Medicine and Pain Medicine, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University of Innsbruck
Department of Anaesthesia and Intensive Care, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck
Medical University of Graz
Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Auenbruggerplatz 5/5, 8036, Graz
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2023-07-19 | 2023-09-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-503717-30-00 blinded | 6.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements blinded | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Medical University Graz blinded | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Medical University Innsbruck blinded | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults blinded | 5.0 |
| Subject information and informed consent form (for publication) | L2_Center specific contacts blinded | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB Propofol | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB Sevorane | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB Suprane | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-503717-30-00 | 3.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-23 | Austria | Acceptable 2023-06-12
|
2023-06-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-18 | Austria | Acceptable 2024-04-09
|
2024-04-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-14 | Austria | Acceptable 2024-10-21
|
2024-10-26 |