Comparison of remimazolam and propofol on incidence of postoperative delirium after hip surgery under general anesthesia

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000038223

Enrollment

Unknown

Registered

2020-09-14

Start date

2021-06-30

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

hip surgery

Interventions

Experimental group:remimazolam

Control group:propofol

Eligibility

Sex/Gender

All

Age

60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Obtaining informed consent; 2. Aged >= 60 and <= 90 years; 3. Patients scheduled to receive hip surgery under general anesthesia; 4. American Society of anesthesiologists (ASA) grade I ~ III.

Exclusion criteria

Exclusion criteria: 1) Patients who have severe heart, lung, liver and kidney dysfunction; 2) Patients who have a history of mental illness or long-term use of psychotropic drugs (dementia, schizophrenia), chronic analgesic drugs, alcoholism; 3) Patients with positive CAM before surgery 4) The preoperative simple mental state questionnaire (SPMSQ) with >= 8 errors was diagnosed as severe cognitive impairment; 5) Any cerebrovascular accidents, such as stroke and transient ischemic attack (TIA), occurred within 3 months; 6) Diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular disease, diabetic nephropathy); 7) Patients with severe infection; 8) PaO2 < 60mmHg or SpO2 < 92% before surgery; 9) Participated in another drug clinical study within the past 30 days; 10) Language communication difficulties, unable to complete the cognitive function test; 11) Patients with prosthesis fracture revision;Patients with hip fracture combined with severe trauma at other sites; 12) Patients with allergy to the test drug or other iliac fascia contraindications.

Design outcomes

Primary

Measure	Time frame
POD incidence within 1 days after surgery;POD incidence within 2 days after surgery;POD incidence within 3 days after surgery;	—

Secondary

Measure	Time frame
Consumption of analgesics;Resting NRS score;Exercise NRS score;Sleep quality before operation;Sleep quality on the first day after operation;Sleep quality on the second day after operation;Intraoperative and postoperative adverse reactions;The mortality rate was 30 days after operation;No hospitalization days 30 days after operation;	—

Countries

China

Contacts

Public ContactLiu Xuesheng

The First Affiliated Hospital of Anhui Medical University

liuxuesheng@ahmu.edu.cn+86 18655193385

Outcome results

None listed

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