Asan Medical Center
Seoul, 05505, South Korea
NCT Number: NCT05644483
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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Notify Me19 year–80 year
All sexes
Interventional
Phase 4
Seoul, 05505, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Remimazolam: loading (6mg/kg/hr) + continuous infusion (1-2mg/kg/hr)
Propofol: target controlled infusion: 2-3mcg/mL
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
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
Time frame: for one hour after turning the patients to the prone position
cardiac index from Flotrac
Time frame: for one hour after turning the patients to the prone position
pleth variability index
Time frame: for one hour after turning the patients to the prone position
heart rate from EKG
Time frame: for one hour after turning the patients to the prone position
amount of total opioid administered
Time frame: for one hour after turning the patients to the prone position
cardiac output from Flotrac
Time frame: for one hour after turning the patients to the prone position
stroke volume from Flotrac
Time frame: for one hour after turning the patients to the prone position
stroke volume variation from Flotrac
Asan Medical Center
Other
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
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