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

Sponsor
Pusan National University Yangsan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05935657
Collaborator
(none)
72
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Incidence of intraoperative bradycardia [Intraoperative period]

      heart rate lower than 45 bpm

    2. Incidence of intraoperative hypertension [Intraoperative period]

      mean blood pressure higher than 120 mmHg or systolic blood pressure higher than 120% of baseline

    3. Incidence of respiratory depression [Intraoperative period]

      respiratory rate lower than 8 per minute

    4. Incidence of hypoxia [Intraoperative period]

      oxygen saturation detected by pulse oxymetry less than 93%

    5. Intraoperative Ramsay sedation scale [Intraoperative period]

      score of 1~6

    6. Number of phenylephrine, ephedrine, atropine administered [Intraoperative period]

      number of administration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pusan National University Yangsan Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gyeong-Jo Byeon, MD, PhD, Associate professor for fund, Pusan National University Yangsan Hospital
    ClinicalTrials.gov Identifier:
    NCT05935657
    Other Study ID Numbers:
    • 20230608
    First Posted:
    Jul 7, 2023
    Last Update Posted:
    Jul 12, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypotension
    Dexmedetomidine

    Study Results

    No Results Posted as of Jul 12, 2023