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

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05935657
• Other study ID #: 20230608
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Pusan National University Yangsan Hospital
• Contact: Jieun Jung, MD
• Phone: 820553602129
• Email: jungje0308[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Remimazolam
• Spinal Anesthesia

Intervention

Drug:
• Remimazolam
0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1~1.0 mg/kg/h continuous infusion
• Dexmedetomidine
1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative hypotension	mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline	Intraoperative period
Secondary	Incidence of intraoperative bradycardia	heart rate lower than 45 bpm	Intraoperative period
Secondary	Incidence of intraoperative hypertension	mean blood pressure higher than 120 mmHg or systolic blood pressure higher than 120% of baseline	Intraoperative period
Secondary	Incidence of respiratory depression	respiratory rate lower than 8 per minute	Intraoperative period
Secondary	Incidence of hypoxia	oxygen saturation detected by pulse oxymetry less than 93%	Intraoperative period
Secondary	Intraoperative Ramsay sedation scale	score of 1~6	Intraoperative period
Secondary	Number of phenylephrine, ephedrine, atropine administered	number of administration	Intraoperative period