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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Anesthesia; Remimazolam
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Remimazolam

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jieun Jung, MD; Phone Number: 820553602129; Email: jungje0308@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam Group; sedation with remimazolam	Drug: Remimazolam; 0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1~1.0 mg/kg/h continuous infusion; Other Names: Byfavo
Active Comparator: Dexmedetomidine group; sedation with dexmedetomidine	Drug: Dexmedetomidine; 1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypotension	mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline	Intraoperative period

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Study Director: Gyengjo Byeon, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 20230608

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No