Effective Dose of Remimazolam for Sedation in Patients Undergoing Lower Extremity Surgery under Spinal Anesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0006828

Enrollment

Registered

2021-12-09

Start date

2022-02-01

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

None listed

Interventions

Drug : Management of basic anesthesia is the same as for patients undergoing lower extremity surgery through all existing spinal anesthesia and sedation. Fasting from midnight the day before surgery,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Age: Adults aged 19 to 65 *Patients with ASA PS 1-3 *Patients receiving sedation using remimazolam among patients undergoing lower extremity surgery under spinal anesthesia

Exclusion criteria

Exclusion criteria: *Patients who refused to participate in the study * Patients with hypersensitivity to benzodiazepines or flumazenil *Patients with severe liver disease *Patients with communication difficulties *Patients with severe obstructive sleep apnea or other diseases expected to difficult airway *Patients who are contraindicated in spinal anesthesia *Patients who are judged unsuitable for participation by medical staff for other reasons

Design outcomes

Primary

Measure	Time frame
A sustained infusion dose of remimazolam that maintains a MOAA/S scale of 3 or less	—

Secondary

Measure	Time frame
respiratory depression;The estimated effect site concentration of that maintains a MOAA/S scale of 3 or less;Blood pressure;Heart rate	—

Countries

Korea, Republic of

Contacts

Public ContactJi-In Park

Asan Medical Center

monica0120120@gmail.com+82-2-3010-1118

Outcome results