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Completed

NCT Number: NCT05644483

Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position

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.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 hepatic disease, acute glaucoma, shock, acute alcohol intoxication
  • allergic to propofol and midazolam
  • patients who are judged unsuitable to participate in the study for other reasons by medical staffs

Treatment and study plan

Remimazolam

Drug

Remimazolam: loading (6mg/kg/hr) + continuous infusion (1-2mg/kg/hr)

Propofol

Drug

Propofol: target controlled infusion: 2-3mcg/mL

Primary outcomes

  1. the number of hypotensive episode per patient

    Time frame: for one hour after turning the patients to the prone position

    SAP < baseline SBP * 80% or 90mmHg // MAP < baseline MAP * 80% or 65mmHg

  2. the number of severe hypotensive episode per patient

    Time frame: for one hour after turning the patients to the prone position

    SAP < baseline SBP * 70% or 80mmHg // MAP < baseline MAP * 70% or 55mmHg

Secondary outcomes

  1. cardiac index

    Time frame: for one hour after turning the patients to the prone position

    cardiac index from Flotrac

  2. pleth variability index

    Time frame: for one hour after turning the patients to the prone position

    pleth variability index

  3. heart rate

    Time frame: for one hour after turning the patients to the prone position

    heart rate from EKG

  4. Total opioid consumption

    Time frame: for one hour after turning the patients to the prone position

    amount of total opioid administered

  5. cardiac output

    Time frame: for one hour after turning the patients to the prone position

    cardiac output from Flotrac

  6. stroke volume

    Time frame: for one hour after turning the patients to the prone position

    stroke volume from Flotrac

  7. stroke volume variation

    Time frame: for one hour after turning the patients to the prone position

    stroke volume variation from Flotrac

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Effect of Remimazolam-remifentanil Versus Propofol-remifentanil Based General Anesthesia on Intraoperative Hemodynamic Stability in Prone Position for Major Spine Surgery: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2022
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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