Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position

Hemodynamic Instability Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644483
• Other study ID #: 2021-1514
• Status: Recruiting
• Phase: Phase 4
• Start date: March 29, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2022
• Source: Asan Medical Center
• Contact: Ha-Jung Kim, MD, PhD
• Phone: 01062987213
• Email: alexakim06[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: September 30, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Drug:
• Remimazolam
Remimazolam: loading (6mg/kg/hr) + continuous infusion (1-2mg/kg/hr)
• Propofol
Propofol: target controlled infusion: 2-3mcg/mL

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of hypotensive episode per patient	SAP < baseline SBP * 80% or 90mmHg // MAP < baseline MAP * 80% or 65mmHg	for one hour after turning the patients to the prone position
Primary	the number of severe hypotensive episode per patient	SAP < baseline SBP * 70% or 80mmHg // MAP < baseline MAP * 70% or 55mmHg	for one hour after turning the patients to the prone position
Secondary	cardiac index	cardiac index from Flotrac	for one hour after turning the patients to the prone position
Secondary	pleth variability index	pleth variability index	for one hour after turning the patients to the prone position
Secondary	heart rate	heart rate from EKG	for one hour after turning the patients to the prone position
Secondary	Total opioid consumption	amount of total opioid administered	for one hour after turning the patients to the prone position
Secondary	cardiac output	cardiac output from Flotrac	for one hour after turning the patients to the prone position
Secondary	stroke volume	stroke volume from Flotrac	for one hour after turning the patients to the prone position
Secondary	stroke volume variation	stroke volume variation from Flotrac	for one hour after turning the patients to the prone position