Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Arthritis Knee; Arthritis Hip

Treatments: Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05760534

H-2301-016-1391

Details and patient eligibility

About

This study aims to compare ideal body weight- and total body weight-based dosage for remimazolam sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia.

Enrollment: 110 patients

Sex: All

Ages: 19 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective knee or hip arthroplasty under spinal anesthesia
• BMI>25
• American Society of Anesthesiologists (ASA) classification I, II, III

Exclusion criteria

• Patient refusal
• Contraindication for spinal anesthesia
• Contraindication for remimazolam infusion
• History of hypersensitivity to remimazolam
• History of chronic use of benzodiazepine or opioid
• Baseline MOAA/S score of 4 or lower
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Ideal body weight group

Experimental group

Treatment:

Drug: Remimazolam

Total body weight group

Active Comparator group

Treatment:

Drug: Remimazolam