Effect of Remimazolam on Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Colon Cancer Surgery: A Randomized Non-inferiority Study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600125477

Enrollment

Unknown

Registered

2026-05-27

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Effect of remimazolam on postoperative delirium in elderly patients undergoing laparoscopic colon cancer surgery

Interventions

Remimazolam group:Anesthesia induction was performed by intravenous bolus injection of remimazolam at 0.2–0.3 mg/kg. Anesthesia was maintained by continuous intravenous infusion of remimazolam at a ra

Propofol group:Anesthesia induction was achieved via intravenous bolus injection of propofol at 1.5–2 mg/kg. Intravenous infusion of propofol at a rate of 4–10 mg/kg/h was administered intraoperativel

Eligibility

Sex/Gender

All

Age

65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Elderly patients aged 65 to 90 years; 2. American Society of Anesthesiologists (ASA) physical status classification grade ?–?; 3. Mini-Mental State Examination score (MMSEs) >=24 points; 4. Elective laparoscopic colon cancer surgery under general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Failure to provide informed consent; 2. Known history of allergy to study drugs; 3. Emergency surgery; 4. Patients with dementia; 5. Hearing impairment; 6. Severe hepatic and renal diseases (Child-Pugh grade C, requiring renal replacement therapy); 7. Patients with severe respiratory diseases; 8. History of neurological or psychiatric diseases and use of antipsychotic drugs; 9. Preoperative Mini-Mental State Examination score (MMSEs) < 24 points.

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative delirium in elderly patients undergoing colon cancer surgery;	—

Secondary

Measure	Time frame
Perioperative hemodynamic fluctuations;Preoperative and postoperative serum IL-6 concentrations;Preoperative and postoperative serum CRP concentrations;Preoperative and postoperative serum TNF-a concentrations;Preoperative and postoperative serum concentrations of tau protein;Preoperative and postoperative serum concentrations of neuron-specific enolase (NSE);Preoperative and postoperative serum concentrations of central nervous system-specific protein S100-ß;Time to first flatus;The incidence of cardiovascular complications;Incidence of pulmonary complications;Incidence of hepatorenal complications;Duration of mechanical ventilation in PACU;	—

Measure

Time frame

Perioperative hemodynamic fluctuations;Preoperative and postoperative serum IL-6 concentrations;Preoperative and postoperative serum CRP concentrations;Preoperative and postoperative serum TNF-a concentrations;Preoperative and postoperative serum concentrations of tau protein;Preoperative and postoperative serum concentrations of neuron-specific enolase (NSE);Preoperative and postoperative serum concentrations of central nervous system-specific protein S100-ß;Time to first flatus;The incidence of cardiovascular complications;Incidence of pulmonary complications;Incidence of hepatorenal complications;Duration of mechanical ventilation in PACU;

—

Countries

China

Contacts

Public ContactYumin Zhu

The affiliated Suzhou hospital of Nanjing Medical University

931470338@qq.com+86 133 0620 6023

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026