Impact of Desflurane and Sevoflurane on Postoperative Delirium in Elderly Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Desflurane
DrugDesflurane 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
DrugSevoflurane 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.
Treatment groups
890 Participants
are divided into 2 treatment groupsGroup A: Sevoflurane groupActive comparator 1 intervention
Group B: Desflurane groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
within 7 days after surgerySecondary outcomes
1
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.
Time frame
The day before surgery and on the 7th day after surgery or discharge2
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).
Time frame
Up to 3 days after surgery3
Length of stay in hospital after surgery.
Length of stay in hospital after surgery
Time frame
Up to 30 days after surgery4
Percentage of intensive care unit (ICU) admission after surgery.
Percentage of intensive care unit (ICU) admission after surgery
Time frame
Within 24 hours after surgeryOther outcomes
1
Cognitive function at 30 days after surgery
Cognitive function assessed with Telephone Interview for Cognitive Status-Modified (TICS-m)
Time frame
On the 30th day after surgery2
TNF-α concentration
Blood specimens will be taken for measuring TNF-α, which is measured with liquid chromatography-mass spectrometry.
Time frame
The day before surgery and 24 hours after surgery. Performed in part of enrolled patients.3
IL-6 concentration
Blood specimens will be taken for measuring IL-6, which is measured with fluorescence immunochromatography
Time frame
The day before surgery and 24 hours after surgery. Performed in part of enrolled patients.Sponsors and contacts
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Source ClinicalTrials.gov