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Impact of Desflurane and Sevoflurane on Postoperative Delirium in Elderly Patients

S

Sichuan University

Status

Enrolling

Conditions

Delirium
Postoperative Cognitive Dysfunction

Treatments

Drug: Sevoflurane
Drug: Desflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT06176144
Approval-No: 2023/1347

Details and patient eligibility

About

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.

Full 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

Enrollment

890 estimated patients

Sex

All

Ages

65 to 90 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

890 participants in 2 patient groups

Sevoflurane group
Active Comparator group
Description:
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.
Treatment:
Drug: Sevoflurane
Desflurane group
Experimental group
Description:
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.
Treatment:
Drug: Desflurane

Trial contacts and locations

1

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Central trial contact

Jing Yang, MD,PhD; Min Xu

Data sourced from clinicaltrials.gov

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