Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position

Last updated: February 24, 2025
Sponsor: Asan Medical Center
Overall Status: Completed

Phase

4

Condition

Low Blood Pressure (Hypotension)

Treatment

Remimazolam

Propofol

Clinical Study ID

NCT05644483
2021-1514
  • Ages 19-80
  • All Genders

Study Summary

Most of the major spinal surgeries are performed in the supine position, which causes a decrease in stroke volume and cardiac index, which leads to the occurrence of hypotension during surgery. Postoperative hypotension causes an imbalance in the supply and demand of oxygen, leading to postoperative myocardial infarction or acute renal damage, and may increase mortality one year after surgery. Propofol, which is most commonly used for total intravenous anesthesia, can further increase the incidence of hypotension during surgery. Therefore, there is a continuing demand for an anesthetic agent that is more hemodynamically stable. Remimazolam, an ultra-short acting benzodiazepine that has a similar structure to midazolam, but whose activity is terminated by esterase hydrolysis, is expected to have less hemodynamic effects than propofol. Therefore, the purpose of this study is to investigate the effect of general anesthesia using remimazolam and general anesthesia using propofol on hemodynamic safety during surgery in patients undergoing major spinal surgery in the supine position.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASA physical status: 1-3

  • age: 19-80 years

  • patients who are scheduled to undergo a major spine surgery in the prone position

Exclusion

Exclusion Criteria:

  • patients who refuse to participate

  • body mass index: <15kg/m2 or >35kg/m2

  • patients with uncontrolled hypertension, hyperthyroidism, severe cardiac disease

  • patients who are contraindicated to the use of remimazolam including severe hepaticdisease, acute glaucoma, shock, acute alcohol intoxication

  • allergic to propofol and midazolam

  • patients who are judged unsuitable to participate in the study for other reasons bymedical staffs

Study Design

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: Remimazolam
Phase: 4
Study Start date:
March 29, 2022
Estimated Completion Date:
January 25, 2023

Connect with a study center

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

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