The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia
Overview
- Phase
- Not Applicable
- Intervention
- Remimazolam
- Conditions
- Remimazolam
- Sponsor
- Pusan National University Yangsan Hospital
- Enrollment
- 72
- Primary Endpoint
- Incidence of intraoperative hypotension
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Gyeong-Jo Byeon, MD, PhD
Associate professor for fund
Pusan National University Yangsan Hospital
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
Arms & Interventions
Remimazolam Group
sedation with remimazolam
Intervention: Remimazolam
Dexmedetomidine group
sedation with dexmedetomidine
Intervention: Dexmedetomidine
Outcomes
Primary Outcomes
Incidence of intraoperative hypotension
Time Frame: Intraoperative period
mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline
Secondary Outcomes
- Intraoperative Ramsay sedation scale(Intraoperative period)
- Incidence of hypoxia(Intraoperative period)
- Incidence of intraoperative bradycardia(Intraoperative period)
- Incidence of intraoperative hypertension(Intraoperative period)
- Incidence of respiratory depression(Intraoperative period)
- Number of phenylephrine, ephedrine, atropine administered(Intraoperative period)