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The Comparison of Remimazolam and Dexmedetomidine on Bradycardia for Patients undergoing lower limb orthopedic surgery using Subarachnoid or Epidural nerve block

The Comparison of Remimazolam and Dexmedetomidine on Bradycardia for Patients undergoing lower limb orthopedic surgery using Subarachnoid or Epidural nerve block

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0007556
Enrollment
44
Registered
2022-07-26
Start date
2022-08-01
Completion date
Unknown
Last updated
2022-09-20

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

Conditions

None listed

Interventions

Drug : After arriving at the block room for regional anesthesia, an electrocardiogram, pulse oximeter, and non-invasive blood pressure monitoring device are attached. All patients were premedicated wi

Sponsors

Korea University Anam Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who have consented to the clinical trial and scheduled for orthopedic lower extremity surgery under regional anesthesia 2. Among patients between the ages of 19 and 80, ASA physical status classification system I-III

Exclusion criteria

Exclusion criteria: 1. Patients who do not consent to clinical trials 2. Patients with spinal anesthesia level higher than T6 3. Patients currently taking beta blocker 4. Patients with a baseline heart rate of less than 50 bpm 5. Patient with previous spine surgery 6. Pregnant woman 7. Patients with body mass index (BMI) 30 kg/m2 8. Patients who are chronic alcoholics or who are taking psychiatric medications for a long time 9. Patients with a history of allergy to previous general anesthetics, patients with hypersensitivity to other benzodiazepines

Design outcomes

Primary

MeasureTime frame
frequency of bradycardia

Secondary

MeasureTime frame
mean Blood pressure;mean heart rate;respiratory depression occurence; Rescue drug (phenylephrine, ephedrine, perdipine, midazolam) usage;Time to recover MOAA/S 4 points after completion of drug administration and time to recover aldrete score 9 points, which is the standard for leaving PACU after drug administration;occurrences of comorbidity (nausea, vomiting, mouth dryness, blurred vision, diziness, delirium)

Countries

Korea, Republic of

Contacts

Public ContactHyunyoung Seong

Korea University Anam Hospital

hello406@naver.com+82-2-920-5632

Outcome results

None listed

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