Sedation With Remimazolam During Spinal Anesthesia

Sedation Clinical Trial

Official title:

Comparison of Sedation With Intravenous Remimazolam and Dexmedetomidine During Spinal Anesthesia : Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305248
• Other study ID #: 3-2021-0489
• Status: Completed
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: May 2023
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Although there have been studies on the use of remimazolam as a sedative for procedures such as endoscopy, there have been no reports of the use of remimazolam in spinal anesthesia. The purpose of this study is to compare and analyze the hemodynamics and recovery profile of patients undergoing surgery under spinal anesthesia by maintaining sedation with dexmedetomidine or remimazolam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Severe cardiovascular or respiratory disease

2. Contraindication to spinal anesthesia

3. Heart block

4. Previous hepatectomy or liver transplant

5. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)

6. Estimated glomerular filtration rate < 30 mL/min/1.73m2

7. Acute narrow angle glaucoma

8. Myasthesia gravis

9. Known allergy to the drugs included in the study

Exclusion Criteria:

1. Patients 19 years of age or older who are expected to elective orthopedic surgery under spinal anaesthesia

2. ASA PS 1-3

Related Conditions & MeSH terms

• Sedation
• Spinal Anesthesia

Intervention

Drug:
• Remimazolam
After spinal anesthesia, 5 mg of remimazolam is injected by intravenous route for 1 minute to induce sedation. To maintain sedation, remimazolam is continuously infused at a rate within the range of 0.1 mg/kg/h to 1 mg/kg/h.
• Dexmedetomidine
After performing spinal anesthesia, dexmedetomidine is injected at a loading dose of 1 mcg/kg for 10 minutes to induce sedation. Thereafter, to maintain sedation, Dexmedetomidine is continuously infused at a rate within the range of 0.2 to 0.7 mcg/kg/h.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MOAA/S score	MOAA/S score will be evaluated by an 5-point scale from iniation of sedative drugs to 30 minutes after PCAU arrival at 10 minutes intervals.	up to 30 minutes after PACU arrival
Secondary	Sedation induction time Sedation induction time	Sedation induction time is defined as from start of drug injection to the first time of MOAA/S = 3	up to 5 minutes after initation of sedative drugs
Secondary	Differences in basic vital signs between the two groups	Differences in blood pressure, heart rate, and patient sedation index at different time points during the operation and PACU stay between the two groups	Baseline