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Comparison of Dexmedetomidine, Remimazolam, and Propofol on the Incidence of Hypotension in Elderly Patients Undergoing Lower Limb Surgery Under Spinal Anesthesia

Comparison of Dexmedetomidine, Remimazolam, and Propofol on the Incidence of Hypotension in Elderly Patients Undergoing Lower Limb Surgery Under Spinal Anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0011444
Enrollment
152
Registered
2026-01-12
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

None listed

Interventions

Drug : Randomize patients who meet the inclusion criteria to one of the following groups: Propofol (Group P), Remimazolam (Group R), or Dexmedetomidine (Group D), with a 1:1:1 allocation ratio. Start

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: * ASA(American Society of Anesthesiologists physical status classification) physical status 1 -4 * Age: Adults 65 years and older * Patients scheduled for lower extremity surgery under sedation and spinal anesthesia with dexmedetomidine, remimazolam, or propofol.

Exclusion criteria

Exclusion criteria: * Informed consent refusal * Uncontrolled hypertension , hyperthyroidism , dementia with inability to communicate , symptomatic coronary artery disease * Allergy to propofol, dexmedetomidine, or remimazolam. * Contraindications to spinal anesthesia such as coagulopathy, severe aortic stenosis/mitral stenosis, active infection onlumbar region, etc. * Any other reason deemed unsuitable by the medical staff to participate in the study.

Design outcomes

Primary

MeasureTime frame
Number of patients with at least one intraoperative hypotension event

Secondary

MeasureTime frame
Number of hypotension events within 1 hour of drug (propofol/remimazolam/dexmedetomidine) administration;Frequency of total hypotension during intraoperative period;Total dose of phenylephrine administered during surgery ;Total amount of fluid infused during surgery;Number of times hypotension occurs in the postoperative recovery room (MBP < 65 mmHg);intraoperative cerebral desaturation event;Postoperative complications (cardiovascular, neurologic, respiratory, delirium, decreased renal function, postoperative nausea and vomiting, decreased cognitive function, etc.);Postoperative Mini-Mental State Examination

Countries

Korea, Republic of

Contacts

Public ContactYeon Ju Kim

Asan Medical Center

clever8808@naver.com+82-2-3010-3888

Outcome results

None listed

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