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

Pusan National University Yangsan Hospital

Status: Not yet enrolling

Conditions: Remimazolam; Spinal Anesthesia

Treatments: Drug: Remimazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05935657

20230608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Remimazolam Group

Experimental group

Description:

sedation with remimazolam

Treatment:

Drug: Remimazolam

Dexmedetomidine group

Active Comparator group

Description:

sedation with dexmedetomidine

Treatment:

Drug: Dexmedetomidine