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Efficacy and safety of Rimimazolam in general anesthesia induction intubation in elderly patients with hypertension: a randomized, single-center, positive drug-controlled clinical trial

Efficacy and safety of Rimimazolam in general anesthesia induction intubation in elderly patients with hypertension: a randomized, single-center, positive drug-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042474
Enrollment
Unknown
Registered
2021-01-22
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

Elderly patients with hypertension

Interventions

Group R:0.3mg/kg rimimazolam
Group B:1.5mg/kg propofol

Sponsors

Chancheng District Central Hospital, Foshan, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 65-80 years old, male or female; (2) ASA I -III grade; (3) P0atients who need endotracheal intubation general anesthesia for elective surgery; undergoing elective surgery (tracheal intubation mechanical ventilation; (4) Patients meet the diagnostic criteria of hypertension (systolic blood pressure = 140mmHg and / or diastolic blood pressure = 90mmHg,or patients diagnosed hypertension and are receiving antihypertensive drugs); (5)The subjects understood and signed the informed consen;

Exclusion criteria

Exclusion criteria: (1) patients With craniocerebral injury or intracranial hypertension; (2) patients emergency surgery,hypovolemia,shock or coma; (3) patients Comorbidities include severe cardiopulmonary,liver and kidney dysfunction; previous history of allergic diseases; (4) patients with seated systolic blood pressure = 90mmHg and heart rate less than 50bpm during screening.; (5)Patients with history of drug abuse or alcohol abuse ; (6)Patients with mental system diseases,Long-term history of taking psychotropic drugs and cognitive dysfunction; (7)Pregnancy or lactation patients; (8)Patients who are allergic or contraindicated to research drugs and their components including benzodiazepine, opioid,and flumazenil; (9)Participated in other intervention clinical trials within 3 months before administration; (10)The researcher think not suitable for this study for other reasons.

Design outcomes

Primary

MeasureTime frame
Percentage of successful anesthesia induction;Incidence of bradycardia;

Secondary

MeasureTime frame
Sedation onset time;Tracheal intubation time;The first intubation success rate;Induction time;Heart rate;Blood pressure;Breath rate;Pulse oxygen saturation;Nacotrend;Modified Observer’s Assessment of Alertne;Other adverse reactions;Percentage of subjects using sedative rescue;Incidence of hypotension;Incidence of hypotension requiring treatment;Incidence of hypertension;Incidence of tachycardia;

Countries

China

Contacts

Public ContactYingchao Xie
904935677@qq.com+86 13690589738

Outcome results

None listed

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