DeliriumNCT06176144
Impact of Desflurane and Sevoflurane on Postoperative Delirium in Elderly Patients
A study testing Desflurane and Sevoflurane in people with Delirium and Postoperative Cognitive Dysfunction, run by West China Hospital at 1 site in China.
Trial summary
Advanced age is a consistent risk factor for the incidence of postoperative cognitive decline, which is associated with longer hospital stays, decreased quality of life, and increased mortality. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium, Postoperative Cognitive Dysfunction
- What is being tested?
- Desflurane and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 890 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years and < 90 years;
- Scheduled to undergo non-cardiac or non-neurosurgery with an expected duration of 2 hours or more, under general anesthesia;
- Agree to participate, and give signed written informed consent.
Who cannot join
- Preoperative history of schizophrenia, epilepsy, parkinsonism or any diseases of central nervous system;
- Inability to communicate in the preoperative period (coma, dementia, language barrier, impaired hearing or vision);
- Severe diseases in cardiovascular, respiratory, liver, kidney, or preoperative American Society of Anesthesiologists physical status classification ≥ IV;
- Alcoholism and drug dependence;
- Other reasons that are considered unsuitable for participation by the responsible surgeons or investigators (reasons must be recorded in the case report form).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, West China Hospital
Chengdu, Sichuan, 610041
Jing Yang, MD, +86- 18980602269, yangjing@wchscu.cn
About this study
Official title: Impact of Desflurane Versus Sevoflurane Anesthesia Maintenance Methods on Incidence of Postoperative Delirium in Elderly Patients
Advanced age is a consistent risk factor for the incidence of postoperative cognitive decline, which is associated with longer hospital stays, decreased quality of life, and increased mortality. Anaesthetic drugs can also affect postoperative cognition, as their residual effects can alter central nervous system activity. Desflurane and sevoflurane are widely used volatile anesthetics. Choice anesthetics may influence the occurrence of postoperative delirium. However, evidence in this aspect is conflicting.
Read the detailed description
With increasing life expectancy, more and more patients aged 65 or older will receive general anesthesia. Rapid recovery from anesthesia may reduce the incidence of many postoperative complications, such as postoperative delirium and cognitive dysfunction. Using inhalational anesthetics is the mainstay of general anesthesia. Since they pass readily into the brain, anesthetics are usually recognized as the important cause of postoperative cognitive dysfunction. Studies have shown that inhalation anesthesia may increase the risk of postoperative delirium in elderly patients compared to propofol, but such studies mostly focus on isoflurane and sevoflurane. Concentrations isoflurane caused aggregation of amyloid peptides in cell cultures, indicating that they brought cytotoxicity to the brain; sevoflurane also showed the same cytotoxic effect. However, some studies showed that inhalational anesthetics had a protective effect on postoperative cognitive function. Desflurane is currently known to be the least biotransformation inhaled anesthetic, whose blood-gas partition coefficient is only 0.42. Desflurane is increasingly used in elderly patients in clinical practice. However, it is not clear whether general anesthesia maintained mainly by desflurane reduces postoperative delirium and early cognitive dysfunction compared with sevoflurane-based general anesthesia
- Conditions
- Delirium, Postoperative Cognitive Dysfunction
- Being tested
- Desflurane, Sevoflurane
- Medical subject headings
- Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Desflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled desflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), and sufentanil (administered by intermittent injection).Towards the end of surgery, desflurane inhalational concentration will be decreased and sufentanil will be administered when necessary. Desflurane inhalation will be stopped at the end of surgery.
SevofluraneDrug
Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection).Towards the end of surgery, sevoflurane inhalational concentration will be decreased and sufentanil will be administered when necessary. Sevoflurane inhalation will be stopped at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group | Active comparator | Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil, sufentanil. Sevoflurane inhalation will be stopped at the end of surgery. Receives: Drug: Sevoflurane |
| Desflurane group | Experimental | Desflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be supplemented with remifentanil, sufentanil. Desflurane inhalation will be stopped at the end of surgery. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative delirium
Delirium is assessed twice daily with the Confusion Assessment Method for patients without endotracheal intubation or the Confusion Assessment Method for the Intensive Care Unit for patients with endotracheal intubation.
Measured: within 7 days after surgery
Secondary outcomes (8)
Quality of recovery, QoR15 (Quality of Recovery 15)
Quality of recovery-15 questionnaire, which consists 15 questions. The score ranges from 0 to 150. The higher the score, the better the quality of recovery.
Measured: The day before surgery and on the 7th day after surgery or discharge
Subjective sleep quality (NRS) within 3 days after surgery.
Subjective sleep quality is assessed once daily with the Numeric Rating Scale (an 11-point rating scale where 0 = the worst sleep and 10 = the best sleep).
Measured: Up to 3 days after surgery
Length of stay in hospital after surgery.
Length of stay in hospital after surgery
Measured: Up to 30 days after surgery
Percentage of intensive care unit (ICU) admission after surgery.
Percentage of intensive care unit (ICU) admission after surgery
Measured: Within 24 hours after surgery
Length of stay in ICU after surgery.
Length of stay in ICU after surgery (in patients admitted to the ICU after surgery)
Measured: Up to 30 days after surgery
Incidence of complications within 30 days
Complications are defined as newly occurred events that are harmful to patients' recovery and required therapeutic intervention
Measured: Up to 30 days after surgery
Intensity of pain within 3 days after surgery
Intensity of pain is assessed twice daily (8-10 AM and 6-8 PM) with the Numeric Rating Scale (an 11-point rating scale where 0 = no pain and 10 = the worst pain).
Measured: Up to 3 days after surgery
Incidence of postoperative cognitive dysfunction (POCD)
Postoperative changes in Neuropsychological Tests score compared with baseline preoperative Neuropsychological Test scores in both the groups.
Measured: The day before surgery and on the 7th day after surgery or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start10 Sep 2023
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 890 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Xu, West China Hospital
- Investigators
- Jing Yang, MD,PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176144
- Sponsor's protocol ID
- Approval-No: 2023/1347
- Status last verified
- Jun 2024
- First submitted
- 21 Nov 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Desflurane Versus Sevoflurane Anesthesia Maintenance Methods on Incidence of Postoperative Delirium in Elderly Patients
- ClinicalTrials.gov ID
- NCT06176144
- Acronym / sponsor ID
- Approval-No: 2023/1347
- Conditions
- Delirium, Postoperative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 890 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advanced age is a consistent risk factor for the incidence of postoperative cognitive decline, which is associated with longer hospital stays, decreased quality of life, and increased mortality. Anaesthetic drugs can also affect postoperative cognition, as their residual effects can alter central nervous system activity. Desflurane and sevoflurane are widely used volatile anesthetics. Choice anesthetics may influence the occurrence of postoperative delirium. However, evidence in this aspect is conflicting.
Detailed description
With increasing life expectancy, more and more patients aged 65 or older will receive general anesthesia. Rapid recovery from anesthesia may reduce the incidence of many postoperative complications, such as postoperative delirium and cognitive dysfunction. Using inhalational anesthetics is the mainstay of general anesthesia. Since they pass readily into the brain, anesthetics are usually recognized as the important cause of postoperative cognitive dysfunction. Studies have shown that inhalation anesthesia may increase the risk of postoperative delirium in elderly patients compared to propofol, but such studies mostly focus on isoflurane and sevoflurane. Concentrations isoflurane caused aggregation of amyloid peptides in cell cultures, indicating that they brought cytotoxicity to the brain; sevoflurane also showed the same cytotoxic effect. However, some studies showed that inhalational anesthetics had a protective effect on postoperative cognitive function. Desflurane is currently known to be the least biotransformation inhaled anesthetic, whose blood-gas partition coefficient is only 0.42. Desflurane is increasingly used in elderly patients in clinical practice. However, it is not clear whether general anesthesia maintained mainly by desflurane reduces postoperative delirium and early cognitive dysfunction compared with sevoflurane-based general anesthesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group | Active comparator | Drug: SevofluraneSevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil, sufentanil. Sevoflurane inhalation will be stopped at the end of surgery. |
| Desflurane group | Experimental | Drug: DesfluraneDesflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be supplemented with remifentanil, sufentanil. Desflurane inhalation will be stopped at the end of surgery. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years and < 90 years;
- Scheduled to undergo non-cardiac or non-neurosurgery with an expected duration of 2 hours or more, under general anesthesia;
- Agree to participate, and give signed written informed consent.
Key exclusion criteria (5 listed)
- Preoperative history of schizophrenia, epilepsy, parkinsonism or any diseases of central nervous system;
- Inability to communicate in the preoperative period (coma, dementia, language barrier, impaired hearing or vision);
- Severe diseases in cardiovascular, respiratory, liver, kidney, or preoperative American Society of Anesthesiologists physical status classification ≥ IV;
- Alcoholism and drug dependence;
- Other reasons that are considered unsuitable for participation by the responsible surgeons or investigators (reasons must be recorded in the case report form).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesfluraneDesflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled desflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), and sufentanil (administered by intermittent injection).Towards the end of surgery, desflurane inhalational concentration will be decreased and sufentanil will be administered when necessary. Desflurane inhalation will be stopped at the end of surgery. | Drug | Desflurane group |
| SevofluraneSevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection).Towards the end of surgery, sevoflurane inhalational concentration will be decreased and sufentanil will be administered when necessary. Sevoflurane inhalation will be stopped at the end of surgery. | Drug | Sevoflurane group |
Primary outcome
postoperative delirium
Time frame: within 7 days after surgery
Delirium is assessed twice daily with the Confusion Assessment Method for patients without endotracheal intubation or the Confusion Assessment Method for the Intensive Care Unit for patients with endotracheal intubation.
8 secondary outcomes
Quality of recovery, QoR15 (Quality of Recovery 15)
Time frame: The day before surgery and on the 7th day after surgery or discharge
Subjective sleep quality (NRS) within 3 days after surgery.
Time frame: Up to 3 days after surgery
Length of stay in hospital after surgery.
Time frame: Up to 30 days after surgery
Percentage of intensive care unit (ICU) admission after surgery.
Time frame: Within 24 hours after surgery
Length of stay in ICU after surgery.
Time frame: Up to 30 days after surgery
Incidence of complications within 30 days
Time frame: Up to 30 days after surgery
Intensity of pain within 3 days after surgery
Time frame: Up to 3 days after surgery
Incidence of postoperative cognitive dysfunction (POCD)
Time frame: The day before surgery and on the 7th day after surgery or discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Yang, MD,PhD principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane and Sevoflurane in people with Delirium and Postoperative Cognitive Dysfunction, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Yang, MD,PhD (+86- 18980602269, yangjing@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative delirium (time frame: within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.