Back to resultsThe Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia
Primary Purpose
Remimazolam, Spinal Anesthesia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remimazolam
Dexmedetomidine
Sponsored by
About this trial
This is an interventional other trial for Remimazolam
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remimazolam Group
Dexmedetomidine group
Arm Description
sedation with remimazolam
sedation with dexmedetomidine
Outcomes
Primary Outcome Measures
Incidence of intraoperative hypotension
mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline
Secondary Outcome Measures
Incidence of intraoperative bradycardia
heart rate lower than 45 bpm
Incidence of intraoperative hypertension
mean blood pressure higher than 120 mmHg or systolic blood pressure higher than 120% of baseline
Incidence of respiratory depression
respiratory rate lower than 8 per minute
Incidence of hypoxia
oxygen saturation detected by pulse oxymetry less than 93%
Intraoperative Ramsay sedation scale
score of 1~6
Number of phenylephrine, ephedrine, atropine administered
number of administration
Full Information
NCT ID
NCT05935657
First Posted
June 28, 2023
Last Updated
August 4, 2023
Sponsor
Pusan National University Yangsan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05935657
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Remimazolam, Spinal Anesthesia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remimazolam Group
Arm Type
Experimental
Arm Description
sedation with remimazolam
Arm Title
Dexmedetomidine group
Arm Type
Active Comparator
Arm Description
sedation with dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Other Intervention Name(s)
Byfavo
Intervention Description
0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1~1.0 mg/kg/h continuous infusion
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2~0.7 mcg/kg/h continuous infusion
Primary Outcome Measure Information:
Title
Incidence of intraoperative hypotension
Description
mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline
Time Frame
Intraoperative period
Secondary Outcome Measure Information:
Title
Incidence of intraoperative bradycardia
Description
heart rate lower than 45 bpm
Time Frame
Intraoperative period
Title
Incidence of intraoperative hypertension
Description
mean blood pressure higher than 120 mmHg or systolic blood pressure higher than 120% of baseline
Time Frame
Intraoperative period
Title
Incidence of respiratory depression
Description
respiratory rate lower than 8 per minute
Time Frame
Intraoperative period
Title
Incidence of hypoxia
Description
oxygen saturation detected by pulse oxymetry less than 93%
Time Frame
Intraoperative period
Title
Intraoperative Ramsay sedation scale
Description
score of 1~6
Time Frame
Intraoperative period
Title
Number of phenylephrine, ephedrine, atropine administered
Description
number of administration
Time Frame
Intraoperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jieun Jung, MD
Phone
820553602129
Email
jungje0308@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gyengjo Byeon, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia
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