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The effect of sodium phosphopropofol on postoperative delirium in elderly patients with gastrointestinal tumors: A multicenter, prospective, randomized controlled trial

The effect of sodium phosphopropofol on postoperative delirium in elderly patients with gastrointestinal tumors: A multicenter, prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118397
Enrollment
Unknown
Registered
2026-02-05
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Tumors

Interventions

The fospropofol group (FP ):Anesthesia Induction: First, midazolam 2-3mg and sufentanil 0.3-0.5µg/kg are administered
then, Fospropofol Disodium 7.5-10mg/kg and rocuronium bromide 0.6mg/kg are given. Tracheal intubation is performed when the MOAA/S score is =55, Fospropofol Disodium is infused at a rate of 10-15mg/kg
The propofol group (P ):Anesthesia Induction: First, midazolam 2-3mg and sufentanil 0.3-0.5µg/kg are administered
then, propofol 1-1.5mg/kg and rocuronium bromide 0.6mg/kg are given. Tracheal intubation is performed when the MOAA/S score is +55, propofol is infused at a rate of 4mg/kg/h, adjusted according to vit

Sponsors

The Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age over 65 years old, gender not limited, BMI=18-30kg/m^2 ; 2. American Society of Anesthesiologists (ASA) I-III level; 3. Gastrointestinal tumor surgery under general anesthesia with a planned duration of over 2 hours. 4. Informed consent, voluntary participation in the trial, and signing of an informed consent form.

Exclusion criteria

Exclusion criteria: 1. delirium was diagnosed before surgery; 2. preoperative cognitive impairment, i.e. MMSE score <17 (illiteracy), <20 (elementary education), <24 (secondary education or above); 3. severe organic disease, such as liver and kidney dysfunction; 4. Severe visual and hearing impairments that hinder communication; 5. a history of mental disorder or long term sedation or depression medication; 6. Patients with known or suspected hypersensitivity or contraindications to the prescribed procedures for various components or protocols of the investigational drug (including sufentanil citrate injection,etomidate, propofol medium/long-chain fatty emulsion, remifentanil hydrochloride for injection,dipropofol disodium for injection, and rocuronium bromide injection). 7. patients with severe coagulation disorders, endocrine diseases, or other conditions affecting hemodynamic status; 8. emergency operation ; 9. The subjects who were not suitable to participate in the study were identified by the researchers.

Design outcomes

Primary

MeasureTime frame
Postoperative delirium incidence;

Secondary

MeasureTime frame
Delirium-related indicators;Drug-related indicators ;Vital sign ;Pain-related indicators;Time related indicators (awakening time, recovery time of orientation after extubation, PACU stay time, postoperative hospital stay);Adverse reactions;

Countries

China

Contacts

Public ContactLi Chao

The Fourth Hospital of Hebei Medical University

jysylichao@163.com+86 138 3111 0738

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026