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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05760534

Collaborator

(none)

110

Enrollment

Arms

11.8

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis Knee Arthritis Hip	Drug: Remimazolam	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 6, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of intraoperative respiratory depression [From entrance to exit from the operating room]
Incidence of intraoperative respiratory depression

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin-Tae Kim, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05760534

Other Study ID Numbers:

H-2301-016-1391

First Posted:

Mar 8, 2023

Last Update Posted:

Mar 8, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Study Results

No Results Posted as of Mar 8, 2023