Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia
- Registration Number
- NCT05760534
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Patients scheduled for elective knee or hip arthroplasty under spinal anesthesia
- BMI>25
- American Society of Anesthesiologists (ASA) classification I, II, III
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ideal body weight group Remimazolam - Total body weight group Remimazolam -
- Primary Outcome Measures
Name Time Method Incidence of intraoperative respiratory depression From entrance to exit from the operating room Incidence of intraoperative respiratory depression
- Secondary Outcome Measures
Name Time Method Incidence of postoperative respiratory depression From entrance to exit from the PACU Respiratory rate \< 8/min or SpO2\<93%
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 hypotension From entrance to exit from the operating room Mean blood pressure \<65 mmHg
Intraoperative Patient State Index (PSi) From entrance to exit from the operating room Continuous monitoring of PSi with Sedline sensor
Length of stay at the post-anesthesia care unit (PACU) From entrance to exit from the PACU Length of stay at the PACU (min)
Incidence of intraoperative tachycardia From entrance to exit from the operating room Heart rate \>120 bpm
Incidence of postoperative hypotension From entrance to exit from the PACU Mean blood pressure \<65 mmHg
Total remimazolam infusion dose From start to end of remimazolam infusion Total remimazolam infusion dose (mg/kg/h)
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 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
Incidence of postoperative hypertension From entrance to exit from the PACU Systolic blood pressure \>120% from baseline
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)
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
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
Incidence of postoperative delirium From end of surgery to third postoperative day Assessment with the Confusion Assessment Method (CAM)