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A comparative study of remimazolam and midazolam in elderly patients during general anesthesia: a randomized controlled study

A comparative study of remimazolam and midazolam in elderly patients during general anesthesia: a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082156
Enrollment
Unknown
Registered
2024-03-22
Start date
2022-12-05
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

None

Interventions

Remimazolam group:Anesthesia induction: A constant infusion rate of remimazolam1 mg/kg/h in Group R until consciousness was disappeared. During maintenance of anesthesia, the remimazolam group was mai
Midazolam group:Anesthesia induction: midazolam 0.1 mg/kg intravenously 20-30 seconds in Group M. Anesthesia maintenance: If the total time exceeds 150 minutes starting from induction of anesthesia to

Sponsors

The Second Affiliated Hospital of Xi'an Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 88 Years

Inclusion criteria

Inclusion criteria: Elderly patients = 65 years old who underwent elective surgery under general anesthesia, regardless of gender; ASA grade I - III; Body mass index = 30kg / m2; The patient or authorized family member voluntarily signed and dated the informed consent, which was approved by the institutional review committee before the patient participated in the study; Patients were willing and able to comply with the study requirements and were able to follow up on the 7th day after operation.

Exclusion criteria

Exclusion criteria: Patients known to be allergic to benzodiazepines, flumazenil, opioids and naloxone, or patients with diseases that prohibit these drugs; Patients with a history of cerebral infarction; Patients treated with benzodiazepines for a long time (such as insomnia, anxiety and spasm); Patients treated with opioids for a long time; Patients with positive drug abuse screening or positive serum ethanol; Patients with a history of drug or alcohol abuse in the past 2 years; Patients who received any investigational drug within 30 days before admission or less than 7 half lives, whichever is longer; Patients who have participated in the clinical trial of remimazolam; Patients who are unable to communicate well with the investigator or who are considered unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
Loss of consciousness time;

Secondary

MeasureTime frame
PACU stay time;Extubation time;

Countries

China

Contacts

Public ContactYang Wanjun

The Second Affiliated Hospital of Xi'an Medical University

631636773@qq.com+86 136 3023 6534

Outcome results

None listed

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