Impact of Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorXijing Hospital

About this trial

The present study is a multicenter, randomized controlled clinical trial, which plans to enroll 450 diabetic patients aged more than 60 years. The participants will be randomly assigned in a 1:1 ratio and will receive either propofol or sevoflurane for intraoperative anesthesia maintenance to evaluate the impact of these two anesthetic drugs on postoperative delirium. The aim of our study is to explore whether the use of propofol for anesthesia maintenance in elderly diabetic patients undergoing elective non-cardiac major surgery can reduce the incidence of postoperative delirium. This study will provide new perspectives for improving perioperative management in elderly diabetic patients and optimizing anesthesia management strategies to reduce the risk of postoperative delirium.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥60 years

Elective surgery (with an expected duration of 2 hours or more)

ASA grade Ⅰ-Ⅲ

Voluntary participation and informed consent obtained

Disqualifiers

Pre-operative BMI≥35 kg/m² (Class II obesity or above)

Severe hepatic dysfunction (Child-Pugh class C) or pre-operative dialysis-dependent renal dysfunction

Known neurological or psychiatric diseases (Parkinson's disease, depression, schizophrenia), or cognitive impairment (dementia)

Severe visual or auditory impairments, language barriers, or patients who cannot cooperate

Trial design

Design model

Parallel

Treatments tested in this trial

  • TIVA ( anesthesia with propofol and remifentanil)

    Drug

    Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery

  • VA(anesthesia with sevoflurane and remifentanil)

    Drug

    Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: TIVAExperimental treatment 1 intervention
Group B: VAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

the incidence of delirium

Postoperative delirium will be assessed daily at 8:00 AM and 6:00 PM from postoperative days 1 to 7, or until discharge, using the 3D-CAM scale.

Time frame
within the first 7 postoperative days

Secondary outcomes

1

The severity of POD

The severity of postoperative delirium will be evaluated with the 4-item CAM-S scale (total score: 7 points, where 0 points indicates no delirium; 1 point indicates mild delirium; 2 points indicates moderate delirium; 3-7 points indicate severe delirium).

Time frame
within the first 7 postoperative days
2

The duration of POD

The total number of days with positive results.

Time frame
within the first 7 postoperative days
3

The length of hospital stay

Time frame
the first 7 postoperative days
4

Blood glucose levels

During the surgery, bedside capillary blood glucose levels will be measured using a portable blood glucose meter (capillary blood).

Time frame
before anesthesia induction (T0), 1 h and 2 h after incision (T1, T2), at skin closure (T3), before PACU discharge (T4), and on post-operative days 1 and 2 (T5, T6)

Other outcomes

1

Serum insulin levels

Time frame
at 1 h and 2 h after incision(T1, T2)
2

Serum inflammatory factor (IL-6) levels

Time frame
post-operative days 1 and 2 (T5, T6)
3

Serum neurodegenerative factor (S-100β protein) levels

Time frame
post-operative days 1 and 2 (T5, T6)

Sponsors and contacts

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