search
Back to results

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

Primary Purpose

Arthritis Knee, Arthritis Hip

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Remimazolam
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis Knee

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ideal body weight group

    Total body weight group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence of intraoperative respiratory depression
    Incidence of intraoperative respiratory depression

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 26, 2023
    Last Updated
    February 26, 2023
    Sponsor
    Seoul National University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05760534
    Brief Title
    Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia
    Official Title
    Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia - a Phase 4 Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 6, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2024 (Anticipated)
    Study Completion Date
    February 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis Knee, Arthritis Hip

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jin-Tae Kim, M.D., Ph.D.
    Phone
    +82-2-2072-2467
    Email
    jintae73@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs