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The effect of remimazolam combined with propofol for general anesthesia on postoperative delirium after major abdominal surgery: A multicenter, prospective, double-blind, randomized controlled study

The effect of remimazolam combined with propofol for general anesthesia on postoperative delirium after major abdominal surgery: A multicenter, prospective, double-blind, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114896
Enrollment
Unknown
Registered
2025-12-18
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Abdominal tumors (including digestive, urinary, gynecological, etc.)

Interventions

Propofol + Remimazolam Group:Intravenous injection of sufentanil 0.3-0.5 µg/kg (60s), followed by intravenous injection of propofol 1-2 mg/kg, followed by intravenous injection of remazolam 0.1~0.2mg/
Propofol + Normal Saline Group:Intravenous injection of sufentanil 0.3-0.5 µg/kg (60s), followed by intravenous injection of propofol 1-2 mg/kg, followed by intravenous injection of 0.1~0.2mg/kg of no

Sponsors

Guangxi Medical University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1:   Age >= 18 years old; 2:   ASA classification grades II to III; 3:   Surgical grade III to IV; 4:   Scheduled abdominal surgery; 5:   A tracheal intubation under general anesthesia is required; 6:   The estimated operation time is >= 2 hours; 7:   Postoperative patient-controlled intravenous analgesia pump for >= 48 hours; 8:   Expected postoperative hospital stay of >= 5 days; 9:   Be able to fully understand the process and methods of this research, voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1:   Those with contraindications to general anesthesia or who have previously experienced allergic reactions to remimazolam or its excipients; 2:   There are cases of difficult airways or those that are judged to be difficult for tracheal intubation (with a modified Mallampati score of level III to IV); 3:   Severe liver dysfunction (Child-Pugh grade C) or severe renal failure (requiring renal replacement therapy); 4:   Patients with myasthenia gravis; 5:   Severe depression state; 6:   History of alcohol abuse or drug dependence; 7:   Abuse or prolonged use of anesthetic, sedative and analgesic drugs; 8:   Those who have a history of mental disorders, epilepsy, or hyperthyroidism/hypothyroidism in the past; 9:   Select those who have participated in any drug clinical trials within the past 1 month; 10:   Those who are unable to communicate due to language barriers or hearing impairments; 11:   Preoperative hemoglobin (HGB) = 20% of the total blood volume.

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative delirium;

Secondary

MeasureTime frame
The incidence rate of cardiovascular adverse events (such as sinus bradycardia, sinus tachycardia, hypotension, hypertension, new-onset arrhythmia, etc.) during the maintenance period;The incidence of acute POD in the PACU;The incidence of postoperative agitation in the PACU;Sleep quality within 1 to 3 days after the surgery;The number of propofol rescue administrations and the average dosage (mg/kg/h) during anesthesia maintenance;Quality score at 1-3 days after surgery;The incidence of delayed awakening in the PACU;The usage rate of flumazenil in the PACU;

Countries

China

Contacts

Public ContactLin Fei

Guangxi Medical University Cancer Hospital

Flylin0208@163.com+86 181 5461 7381

Outcome results

None listed

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