Incidence of postoperative hypotension after remimazolam or dexmedetomidine sedation in patients undergoing hip arthroplasty under spinal anesthesia

Incidence of postoperative hypotension after remimazolam or dexmedetomidine sedation in patients undergoing unilateral total hip arthroplasty under spinal anesthesia: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008223

Enrollment

108

Registered

2023-02-23

Start date

2023-02-23

Completion date

Unknown

Last updated

2024-07-23

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

Conditions

None listed

Interventions

Drug : Participants are randomized at 1:1 ratio to 1) Remimazolam group and 2) Dexmedetomidine group. After spinal anesthesia and confirmation of sensory and motor block level, sedation is initiated w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of age 19 to 80 scheduled for unilateral total hip arthroplasty under spinal anesthesia requiring intraoperative sedation

Exclusion criteria

Exclusion criteria: ? Patient refusal ? Contraindication to spinal anesthesia i. Patient refusal ii. Increased intracranial pressure iii. Infection of needle insertion area iv. Underlying neurologic disease v. Severe hypovolemia vi. Aortic or mitral stenosis vii. Thrombocytopenia or coagulopathy ? Contraindication to remimazolam or dexmedetomidine ? History of hypersensitivity to remimazolam or dexmedetomidine ? Baseline MOAA/S score lower than 5 ? Pregnancy ? Other cases deemed inappropriate by investigators

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative hypotension (MBP<65 mmHg) after unilateral total hip arthroplasty under spinal anesthesia and sedation with dexmedetomidine or remimazolam	—

Secondary

Measure	Time frame
number of rescue sedative (midazolam) dose;sensory block level;estimated blood loss (mL);transfusion (mL);Administered fluids (mL);Urinary output (mL);Incidence of hypotension (MBP140 mmHg);Incidence of tachycardia (heart rate>110 beats per min);Incidence of bradycardia (heart rate140 mmHg);Incidence of tachycardia (heart rate>110 beats per min);Incidence of bradycardia (heart rate<45 beats per min);Vasopressor used during postanesthesia care unit stay;Vasopressor dose used during postanesthesia care unit stay;Vasopressor administration time during postanesthesia care unit stay;Transfusion during postanesthesia care unit stay (mL);Fluid administratino during postanesthesia care unit stay (mL);Urinary output during postanesthesia care unit stay (mL);Respiratory depression during PACU stay (SpO2<93% or respiratory rate <8/min);Incidence of delirium;Incidence of tranfer to intensive care unit;Patient satisfaction (numeric rating scale, 0 not satisfied at all, 10 completely satisfied)	—

Measure

Time frame

number of rescue sedative (midazolam) dose;sensory block level;estimated blood loss (mL);transfusion (mL);Administered fluids (mL);Urinary output (mL);Incidence of hypotension (MBP140 mmHg);Incidence of tachycardia (heart rate>110 beats per min);Incidence of bradycardia (heart rate140 mmHg);Incidence of tachycardia (heart rate>110 beats per min);Incidence of bradycardia (heart rate<45 beats per min);Vasopressor used during postanesthesia care unit stay;Vasopressor dose used during postanesthesia care unit stay;Vasopressor administration time during postanesthesia care unit stay;Transfusion during postanesthesia care unit stay (mL);Fluid administratino during postanesthesia care unit stay (mL);Urinary output during postanesthesia care unit stay (mL);Respiratory depression during PACU stay (SpO2<93% or respiratory rate <8/min);Incidence of delirium;Incidence of tranfer to intensive care unit;Patient satisfaction (numeric rating scale, 0 not satisfied at all, 10 completely satisfied)

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Countries

Korea, Republic of

Contacts

Public ContactHansol Kim

Seoul National University Hospital

hansolfrkr@gmail.com+82-2-2072-3280

Outcome results