Safety and effcacy of remimazolam for sedation during combined spinal-epidural anesthesia for orthopedic procedures:a randomized controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200066642

Enrollment

Unknown

Registered

2022-12-12

Start date

2022-12-15

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

None listed

Interventions

control group:Dexmedetomidine

remimazolam group:remimazolam

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 40 ~ 80 years old 2. Orthopedic surgery under combined spinal-epidural anesthesia is planned. 3. Body mass index (BMI) is 18 ~ 28kg/?. 4. American Association of Anesthesiologists (ASA) Grade I ~ III

Exclusion criteria

Exclusion criteria: 1. Patients with heart, brain, lung, liver, kidney and other major organ diseases 2. People with severe physical illness, cognitive dysfunction, mental illness and language communication disorder. 3. Those who do not cooperate with the experiment and do not sign the consent form. 4. Alcoholics and drug abusers 5. Long-term use of sedatives, analgesics and chronic alcoholics. 6. Changes of anesthesia mode during operation. 7. During the operation, the circulation fluctuates violently due to the operation. 8. Lost follow-up, no curative effect and safety data were collected. 9. Contraindications of spinal anesthesia

Design outcomes

Primary

Measure	Time frame
Sedation onset time;	—

Secondary

Measure	Time frame
blood pressure;heart rate;Respiratory rate;degree of blood oxygen saturation;degree of satisfaction;BMI;Ramsay sedation score;BIS;	—

Countries

China

Contacts

Public ContactXue Rui

People Hospital of Shiyan City

xuerui1106@126.com+86 13476167178

Outcome results