The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia

NCT ID: NCT05935657

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-06-30

Brief Summary

The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.

Detailed Description

Sedation during spinal anesthesia can reduce the patient's anxiety and increase satisfaction, but sedatives such as dexmedetomidine and midazolam may cause hemodynamic instability such as hypotension and bradycardia. In previous studies , hypotension occurred in about 33% and bradycardia in about 13% during spinal anesthesia, which is related to reduced cardiac output due to sympathetic blockade and relative activation of the parasympathetic nerve.

In the study comparing remimazolam and dexmedetomidine in patients with delirium after orthopedic surgery, the incidence of hypotension was lower in the remimazolam group (10.8%) than in the dexmedetomidine group (39.5%) (p=0.007) and there was no significant difference between the remimazolam group (2.7%) and the dexmedetomidine group (13.2%) in the incidence of bradycardia (p=0.200).

However, the effect of remimazolam on the incidence of hypotension during spinal anesthesia has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adults patients.

Conditions

Remimazolam; Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Remimazolam Group

sedation with remimazolam

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1\~1.0 mg/kg/h continuous infusion

Dexmedetomidine group

sedation with dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2\~0.7 mcg/kg/h continuous infusion

Interventions

Remimazolam

0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1\~1.0 mg/kg/h continuous infusion

Intervention Type: DRUG

Dexmedetomidine

1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2\~0.7 mcg/kg/h continuous infusion

Intervention Type: DRUG

Other Intervention Names

Byfavo; Precedex

Eligibility Criteria

Inclusion Criteria

• Patient scheduled for surgery under spinal anesthesia, aged 19-79, of ASA class I, II, or III

Exclusion Criteria

• Patient refusal
• Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis)
• Contraindications or allergy to dexmedetomidine or remimazolam administration
• Emergency surgery
• Pregnancy

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gyeong-Jo Byeon, MD, PhD

Associate professor for fund

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gyengjo Byeon, PhD

Role: STUDY_DIRECTOR

Pusan National University Yangsan Hospital

Central Contacts

Jieun Jung, MD

Role: CONTACT

jungje0308@gmail.com

820553602129

Other Identifiers

20230608

Identifier Type: -

Identifier Source: org_study_id