Clinical trial NCT05935657: The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia
Official title: The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Remimazolam
Spinal Anesthesia
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Incidence of intraoperative hypotension
timeFrame: Intraoperative period
Secondary outcomes:
measure: Incidence of intraoperative bradycardia
timeFrame: Intraoperative period
measure: Incidence of intraoperative hypertension
timeFrame: Intraoperative period
measure: Incidence of respiratory depression
timeFrame: Intraoperative period
measure: Incidence of hypoxia
timeFrame: Intraoperative period
measure: Intraoperative Ramsay sedation scale
timeFrame: Intraoperative period
measure: Number of phenylephrine, ephedrine, atropine administered
timeFrame: Intraoperative period
Other outcomes:
Locations:
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Gyengjo Byeon, PhD
role: STUDY_DIRECTOR
References: