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The effect of maintenance of anesthesia with remimazolam besylate and propofol on the quality of recovery in elderly patients undergoing gastrointestinal tumor surgery

The effect of maintenance of anesthesia with remimazolam besylate and propofol on the quality of recovery in elderly patients undergoing gastrointestinal tumor surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085773
Enrollment
Unknown
Registered
2024-06-18
Start date
2024-06-24
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

General anesthesia maintenance in elderly patients undergoing gastrointestinal tumor surgery

Interventions

Group R:Continuous infusion of remazolam besylate during surgery, anesthesia maintenance, intervention group
Group P:Continuous infusion of propofol during surgery, maintained anesthesia, control group

Sponsors

Beijing Shijitan Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age 65 and above; (2) American Society of Anesthesiologists (ASA I-III); (3) Patients undergoing gastrointestinal tumor surgery with elective general anesthesia (intravenous anesthesia) and tracheal intubation; (4) Informed consent, voluntary participation in the experiment, and signing of an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Heart function level 3 or above; Severe liver and kidney disease (Child grade C, patients undergoing renal replacement therapy) (2) Patients undergoing surgery for other systemic tumors; (3) Patients undergoing multimodal anesthesia methods such as compound spinal anesthesia; (4) Patients who are known to be allergic to remazolam benzenesulfonate or benzodiazepines; (5) Patients with abnormal coagulation function, endocrine disorders, or other factors affecting hemodynamic status; (6) Short surgery time (surgery duration<4 hours); (7) Preoperative mental illness (Parkinson's disease, senile dementia), various reasons such as hearing and vision, and inability to fully communicate with others; (8) Patients with a history of drug and alcohol dependence; (9) Subjects deemed unsuitable by the researchers to participate in this study; (10) Participants in other clinical trials within the three months prior to being selected for the study.

Design outcomes

Primary

MeasureTime frame
Postoperative recovery time for patients (defined as the period from the end of surgery to the recovery of consciousness, spontaneous breathing, and removal of tracheal catheters);

Secondary

MeasureTime frame
awakening quality;Record anesthesia induction time, awakening time, PACU/ICU residence time, surgical time, fluid intake and output, dosage of anesthetic and vasoactive drugs, and incidence of intraoperative hypotension (mean arterial pressure below 65mmHg, or a decrease of more than 20% from baseline);Using the Montreal Cognitive Assessment Scale (MoCA) to assess cognitive function 1 day before surgery (T0) and 1-3 days after surgery;Short CAM and ICU-CAM were used to evaluate the incidence of delirium at 1 day (T6), 2 days (T7), and 3 days (T8) after surgery;Use Visual Analog Scale (NRS) to evaluate the patient's sleep and pain levels 1 day before surgery and 1-3 days after surgery;Record hospitalization time and incidence of adverse events (pain, nausea and vomiting, allergies, respiratory depression, hypotension, delayed awakening, etc.);

Countries

China

Contacts

Public ContactZhang Jing

Beijing Shijitan Hospital,Capital Medical University

Yasandy22@126.com+86 135 8158 5698

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026