NCT05935657

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Remimazolam	0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1\~1.0 mg/kg/h continuous infusion
DRUG	Dexmedetomidine	1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2\~0.7 mcg/kg/h continuous infusion

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2023-07-07
• Last updated: 2023-08-08