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

Sponsor

Asan Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05379777

Collaborator

(none)

Enrollment

Location

Arm

7.7

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Remimazolam Orthopedic Procedures Sedatives Anesthesia, Spinal	Drug: Remimazolam	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Determination of Effective Dose 90 of Remimazolam That Can Maintain Loos of Consciousness From Sedation With Remimazolam in Adult Patients

Actual Study Start Date :

May 11, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam A maintenance dose of remimazolam is administered for sedation	Drug: Remimazolam 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.)

Arm

Intervention/Treatment

Experimental: Remimazolam

A maintenance dose of remimazolam is administered for sedation

Drug: Remimazolam

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.)

Outcome Measures

Primary Outcome Measures

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

Frequency of respiratory depression [throughout the surgery]
respiratory rate equal or less than 6 time per minute

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

Asan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hajung Kim, Clinical Assistant Professor, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT05379777

Other Study ID Numbers:

2021-1638

First Posted:

May 18, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 16, 2022