Effective Dose of Remimazolam for Sedation in Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia

Phase 4

Completed

• Conditions: Sedatives; Remimazolam; Orthopedic Procedures; Anesthesia, Spinal
• Interventions: Drug: Remimazolam

• Registration Number: NCT05379777
• Lead Sponsor: Asan Medical Center

Brief Summary

Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has different advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. In addition, remimazolam has a very short onset time, and even after the continuous infusion, the onset of remimazolam is fast, and even after continuous injection, the effect disappeared very quickly due to the short context-sensitive half time. and through continuous infusion, the patient's depth of anesthesia can be maintained constant. In addition, the short duration of action and the ability to quickly reverse the effect of flumazenil suggest that remimazolam can be used effectively under general anesthesia as well as under general anesthesia. Remimazolam can be used as a continuous infusion for general anesthesia. However, it has also been reported to be used for sedation by continuous infusion or divided intravenous infusion. However, the effective infusion dose of remimazolam for supervised general anesthesia without mechanical ventilation has not been established.

In this study, the ED90 of the maintenance dose that maintain loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of remimazolam after spinal anesthesia is obtained.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-11
• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-18
• Primary Completion: 2022-08-24
• Study Completion: 2022-08-24
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• ASA PS 1-3
• Patients undergoing lower extremity surgery under spinal anesthesia and sedation using remimazolam

Exclusion Criteria

• Patients who refuse to participate in this study
• Patients with hypersensitivity to benzodiazepine or flumazenil
• Patients with severe renal/hepatic disease
• Patients with drug/alcohol abuse
• Patients who take antidepressants, anticonvulsants, psychoactive drugs chronically
• Patients with difficulty in communication
• Patients with severe obstructive sleep apnea or other airway problems
• Patients contraindicated to regional anesthesia
• Patients judged to be inappropriate for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remimazolam	Remimazolam	A maintenance dose of remimazolam is administered for sedation

Primary Outcome Measures

Name	Time	Method
success or failure of sedation maintenace	throughout the surgery	MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)

Secondary Outcome Measures

Name	Time	Method
Frequency of respiratory depression	throughout the surgery	respiratory rate equal or less than 6 time per minute

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of