Clinical trial NCT05760534: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arthritis Knee
Arthritis Hip
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of intraoperative respiratory depression
timeFrame: From entrance to exit from the operating room
Secondary outcomes:
measure: Total remimazolam infusion dose
timeFrame: From start to end of remimazolam infusion
measure: Incidence of intraoperative hypotension
timeFrame: From entrance to exit from the operating room
measure: Incidence of intraoperative hypertension
timeFrame: From entrance to exit from the operating room
measure: Incidence of intraoperative bradycardia
timeFrame: From entrance to exit from the operating room
measure: Incidence of intraoperative tachycardia
timeFrame: From entrance to exit from the operating room
measure: Incidence of intraoperative oxygen desaturation
timeFrame: From entrance to exit from the operating room
measure: Incidence of intraoperative nausea or vomiting
timeFrame: From entrance to exit from the operating room
measure: Incidence of intraoperative hiccups
timeFrame: From entrance to exit from the operating room
measure: Incidence of intraoperative paradoxical movements
timeFrame: From entrance to exit from the operating room
measure: Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score
timeFrame: From start of remimazolam infusion until time of full alertness
measure: Intraoperative Patient State Index (PSi)
timeFrame: From entrance to exit from the operating room
measure: Time to reach MOAA/S score 5 after end of surgery
timeFrame: From end of remimazolam infusion until time of full alertness
measure: Length of stay at the post-anesthesia care unit (PACU)
timeFrame: From entrance to exit from the PACU
measure: Patient satisfaction
timeFrame: At exit from PACU
measure: Intraoperative recall
timeFrame: At exit from PACU
measure: Incidence of postoperative nausea or vomiting
timeFrame: From entrance to exit from the PACU
measure: Incidence of postoperative delirium
timeFrame: From end of surgery to third postoperative day
measure: Incidence of postoperative respiratory depression
timeFrame: From entrance to exit from the PACU
measure: Incidence of postoperative hypotension
timeFrame: From entrance to exit from the PACU
measure: Incidence of postoperative hypertension
timeFrame: From entrance to exit from the PACU
Other outcomes:
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