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Comparison in frequency of hypotension during perioperative period for sedation of dexmedetomidine and remimazolam in patients undergoing spinal anesthesia for low extremity surgery: a randomized controlled clinical trial

Comparison in frequency of hypotension during perioperative period for sedation of dexmedetomidine and remimazolam in patients undergoing spinal anesthesia for low extremity surgery: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0007138
Enrollment
74
Registered
2022-04-01
Start date
2022-04-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

None listed

Interventions

Drug : Perform anesthesia according to general spinal anesthesia.For single-blinded trial, do not tell the patient which sedatives to use or not. After standard monitoring, spinal anesthesia is perfor

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 to 80 years 2) Patients scheduled for regular schedule and receiving spinal anesthesia for lower extremity surgery 3) ASA physical status 1-3 4) Patients who voluntarily consented in writing to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1) Patients who do not consent to study participation 2) Patients with adverse reactions to bupivacaine, dexmedetomidine, remimazolam, phenylephrine, nicardipine, esmolol, or atropine 3) Patients planned not to be sedated during surgery 4) Patients with uncontrolled medical or psychiatric problems 5) Pregnant or lactating patients 6) Patients whose spinal anesthesia range is greater than T8 7) Patients who are judged unsuitable for participation by medical staff for other reasons

Design outcomes

Primary

MeasureTime frame
Frequency of hypotensive episodes in two groups (patients using dexmedetomidine or remimazolam) who underwent spinal anesthesia for lower extremity surgery

Secondary

MeasureTime frame
Total dose of vasopressors (ephedrine, phenylephrine) administered ;Total amount of fluid;Frequency of hypertensive episodes per hour;Postoperative complications (cardiovascular, neurological, respiratory, delirium, renal function decline, postoperative nausea, vomiting, etc.);sedation score

Countries

Korea, Republic of

Contacts

Public ContactJong-Hyuk Lee

Asan Medical Center

guboouki@naver.com+82-2-3010-1416

Outcome results

None listed

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