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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
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
Jin-Tae Kim
Seoul, South Korea
Incidence of intraoperative respiratory depression
Incidence of intraoperative respiratory depression
Time frame: From entrance to exit from the operating room
Total remimazolam infusion dose
Total remimazolam infusion dose (mg/kg/h)
Time frame: From start to end of remimazolam infusion
Incidence of intraoperative hypotension
Mean blood pressure \<65 mmHg
Time frame: From entrance to exit from the operating room
Incidence of intraoperative hypertension
Systolic blood pressure \>120% of baseline
Time frame: From entrance to exit from the operating room
Incidence of intraoperative bradycardia
Heart rate \<45 bpm
Time frame: From entrance to exit from the operating room
Incidence of intraoperative tachycardia
Heart rate \>120 bpm
Time frame: From entrance to exit from the operating room
Incidence of intraoperative oxygen desaturation
Pulse oximeter saturation (SpO2) \< 93%
Time frame: From entrance to exit from the operating room
Incidence of intraoperative nausea or vomiting
Nausea or vomiting during surgery
Time frame: From entrance to exit from the operating room
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Incidence of intraoperative hiccups
Hiccups during surgery
Time frame: From entrance to exit from the operating room
Incidence of intraoperative paradoxical movements
Paradoxical movements during surgery
Time frame: 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
Time frame: From start of remimazolam infusion until time of full alertness
Intraoperative Patient State Index (PSi)
Continuous monitoring of PSi with Sedline sensor
Time frame: 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)
Time frame: 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)
Time frame: From entrance to exit from the PACU
Patient satisfaction
Numeric rating scale of 0 (not satisfied at all) to 10 (absolutely satisfied)
Time frame: At exit from PACU
Intraoperative recall
Assessment with the modified Brice questionnaire
Time frame: At exit from PACU
Incidence of postoperative nausea or vomiting
Incidence of nausea or vomiting
Time frame: From entrance to exit from the PACU
Incidence of postoperative delirium
Assessment with the Confusion Assessment Method (CAM)
Time frame: From end of surgery to third postoperative day
Incidence of postoperative respiratory depression
Respiratory rate \< 8/min or SpO2\<93%
Time frame: From entrance to exit from the PACU
Incidence of postoperative hypotension
Mean blood pressure \<65 mmHg
Time frame: From entrance to exit from the PACU
Incidence of postoperative hypertension
Systolic blood pressure \>120% from baseline
Time frame: From entrance to exit from the PACU