Clinical trial NCT05644483: Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamic Instability
Keywords: propofol
remimazolam
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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

Primary outcomes:
measure: the number of hypotensive episode per patient
timeFrame: for one hour after turning the patients to the prone position
measure: the number of severe hypotensive episode per patient
timeFrame: for one hour after turning the patients to the prone position
Secondary outcomes:
measure: cardiac index
timeFrame: for one hour after turning the patients to the prone position
measure: pleth variability index
timeFrame: for one hour after turning the patients to the prone position
measure: heart rate
timeFrame: for one hour after turning the patients to the prone position
measure: Total opioid consumption
timeFrame: for one hour after turning the patients to the prone position
measure: cardiac output
timeFrame: for one hour after turning the patients to the prone position
measure: stroke volume
timeFrame: for one hour after turning the patients to the prone position
measure: stroke volume variation
timeFrame: for one hour after turning the patients to the prone position
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: