Impact of Desflurane and Sevoflurane on Postoperative Delirium in Elderly Patients

Delirium Clinical Trial

Official title:

Impact of Desflurane Versus Sevoflurane Anesthesia Maintenance Methods on Incidence of Postoperative Delirium in Elderly Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06176144
• Other study ID #: Approval-No: 2023/1347
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: West China Hospital
• Contact: Jing Yang, MD,PhD
• Phone: +86- 18980602269
• Email: yangjing[@]wchscu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 890
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age = 65 years and < 90 years;

2. Scheduled to undergo non-cardiac or non-neurosurgery with an expected duration of 2 hours or more, under general anesthesia;

3. Agree to participate, and give signed written informed consent.

Exclusion Criteria:

1. Preoperative history of schizophrenia, epilepsy, parkinsonism or any diseases of central nervous system;

2. Inability to communicate in the preoperative period (coma, dementia, language barrier, impaired hearing or vision);

3. Severe diseases in cardiovascular, respiratory, liver, kidney, or preoperative American Society of Anesthesiologists physical status classification = IV;

4. Alcoholism and drug dependence;

5. Other reasons that are considered unsuitable for participation by the responsible surgeons or investigators (reasons must be recorded in the case report form).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Emergence Delirium
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

Drug:
• Desflurane
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.
• Sevoflurane
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.

Locations

Country	Name	City	State
China	Department of Anesthesiology, West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function at 30 days after surgery	Cognitive function assessed with Telephone Interview for Cognitive Status-Modified (TICS-m)	On the 30th day after surgery
Other	TNF-a concentration	Blood specimens will be taken for measuring TNF-a, which is measured with liquid chromatography-mass spectrometry.	The day before surgery and 24 hours after surgery. Performed in part of enrolled patients.
Other	IL-6 concentration	Blood specimens will be taken for measuring IL-6, which is measured with fluorescence immunochromatography	The day before surgery and 24 hours after surgery. Performed in part of enrolled patients.
Primary	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.	within 7 days after surgery
Secondary	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.	The day before surgery and on the 7th day after surgery or discharge
Secondary	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).	Up to 3 days after surgery
Secondary	Length of stay in hospital after surgery.	Length of stay in hospital after surgery	Up to 30 days after surgery
Secondary	Percentage of intensive care unit (ICU) admission after surgery.	Percentage of intensive care unit (ICU) admission after surgery	Within 24 hours after surgery
Secondary	Length of stay in ICU after surgery.	Length of stay in ICU after surgery (in patients admitted to the ICU after surgery)	Up to 30 days after surgery
Secondary	Incidence of complications within 30 days	Complications are defined as newly occurred events that are harmful to patients' recovery and required therapeutic intervention	Up to 30 days after surgery
Secondary	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).	Up to 3 days after surgery
Secondary	Incidence of postoperative cognitive dysfunction (POCD)	Postoperative changes in Neuropsychological Tests score compared with baseline preoperative Neuropsychological Test scores in both the groups.	The day before surgery and on the 7th day after surgery or discharge