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

NCT05379777 | Completed Phase 4

• 1 other identifier: 2021-1638
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Remimazolam; Orthopedic Procedures; Sedatives; Anesthesia, Spinal

Outcome Measures

Primary Outcomes (1)

• success or failure of sedation maintenace

  MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)

  throughout the surgery

Secondary Outcomes (1)

• Frequency of respiratory depression

  throughout the surgery

Study Arms (1)

Remimazolam

EXPERIMENTAL

A maintenance dose of remimazolam is administered for sedation

Drug: Remimazolam

Interventions

Remimazolam DRUG

Remimazolam The starting dose of remimazolam is 1 mg/kg/hr. If sedation does not proceed successfully, increase the infusion rate by 0.2 mg/kg/hr in the next patient. (However, if the infusion rate is less than 0.6mg/kg/hr, the dose is increased by 0.1mg/kg/hr.) If sedation has progressed successfully until the end of surgery, the next patient will use the same dose with a probability of 0.89 or 0.11 It is reduced by 0.2 mg/kg/hr with a probability of (However, if the infusion rate is 0.6mg/kg/hr or less, reduce it by 0.1mg/kg/hr.)

Remimazolam

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

remimazolam

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: May 11, 2022
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

KR (1)