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

Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia - a Phase 4 Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Arthritis Knee; Arthritis Hip
• Intervention / Treatment: Drug: Remimazolam

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ideal body weight group	Drug: Remimazolam; 0.075 mg/kg Remimazolam will be loaded over 1 min, then continuously infused at 0.2-1.0 mg/kg/h based on ideal or total body weight
Active Comparator: Total body weight group	Drug: Remimazolam; 0.075 mg/kg Remimazolam will be loaded over 1 min, then continuously infused at 0.2-1.0 mg/kg/h based on ideal or total body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative respiratory depression	Incidence of intraoperative respiratory depression	From entrance to exit from the operating room

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total remimazolam infusion dose	Total remimazolam infusion dose (mg/kg/h)	From start to end of remimazolam infusion
Incidence of intraoperative hypotension	Mean blood pressure <65 mmHg	From entrance to exit from the operating room
Incidence of intraoperative hypertension	Systolic blood pressure >120% of baseline	From entrance to exit from the operating room
Incidence of intraoperative bradycardia	Heart rate <45 bpm	From entrance to exit from the operating room
Incidence of intraoperative tachycardia	Heart rate >120 bpm	From entrance to exit from the operating room
Incidence of intraoperative oxygen desaturation	Pulse oximeter saturation (SpO2) < 93%	From entrance to exit from the operating room
Incidence of intraoperative nausea or vomiting	Nausea or vomiting during surgery	From entrance to exit from the operating room
Incidence of intraoperative hiccups	Hiccups during surgery	From entrance to exit from the operating room
Incidence of intraoperative paradoxical movements	Paradoxical movements during surgery	From entrance to exit from the operating room
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score	MOAA/S score assessment at 10 min intervals	From start of remimazolam infusion until time of full alertness
Intraoperative Patient State Index (PSi)	Continuous monitoring of PSi with Sedline sensor	From entrance to exit from the operating room
Time to reach MOAA/S score 5 after end of surgery	Time to reach MOAA/S score 5 (min)	From end of remimazolam infusion until time of full alertness
Length of stay at the post-anesthesia care unit (PACU)	Length of stay at the PACU (min)	From entrance to exit from the PACU
Patient satisfaction	Numeric rating scale of 0 (not satisfied at all) to 10 (absolutely satisfied)	At exit from PACU
Intraoperative recall	Assessment with the modified Brice questionnaire	At exit from PACU
Incidence of postoperative nausea or vomiting	Incidence of nausea or vomiting	From entrance to exit from the PACU
Incidence of postoperative delirium	Assessment with the Confusion Assessment Method (CAM)	From end of surgery to third postoperative day
Incidence of postoperative respiratory depression	Respiratory rate < 8/min or SpO2<93%	From entrance to exit from the PACU
Incidence of postoperative hypotension	Mean blood pressure <65 mmHg	From entrance to exit from the PACU
Incidence of postoperative hypertension	Systolic blood pressure >120% from baseline	From entrance to exit from the PACU

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jin-Tae Kim, M.D., Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): November 25, 2025
• Study Completion (Actual): November 25, 2025

Study Registration Dates

• First Submitted: February 26, 2023
• First Submitted That Met QC Criteria: February 26, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: remimazolam
• Other Study ID Numbers: H-2301-016-1391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No