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

Not Applicable

Not yet recruiting

• Conditions: Spinal Anesthesia; Remimazolam
• Interventions: Drug: Remimazolam; Drug: Dexmedetomidine

• Registration Number: NCT05935657
• Lead Sponsor: Pusan National University Yangsan Hospital

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.

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-07
• Status Verified: 2023-08
• Study Start: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-08
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam Group	Remimazolam	sedation with remimazolam
Dexmedetomidine group	Dexmedetomidine	sedation with dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative hypotension	Intraoperative period	mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline

Secondary Outcome Measures

Name	Time	Method
Intraoperative Ramsay sedation scale	Intraoperative period	score of 1\~6
Incidence of hypoxia	Intraoperative period	oxygen saturation detected by pulse oxymetry less than 93%
Incidence of intraoperative bradycardia	Intraoperative period	heart rate lower than 45 bpm
Incidence of intraoperative hypertension	Intraoperative period	mean blood pressure higher than 120 mmHg or systolic blood pressure higher than 120% of baseline
Incidence of respiratory depression	Intraoperative period	respiratory rate lower than 8 per minute
Number of phenylephrine, ephedrine, atropine administered	Intraoperative period	number of administration