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

Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05760534
• Other study ID #: H-2301-016-1391
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 6, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2023
• Source: Seoul National University Hospital
• Contact: Jin-Tae Kim, M.D., Ph.D.
• Phone: +82-2-2072-2467
• Email: jintae73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis Hip
• Arthritis Knee

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

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