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The trial groups will be:
Anesthesia will be maintained for the entire surgical procedure per clinical routine. At the end of the surgical procedure, patients will be extubated and transferred to the post anesthesia care unit (PACU).
Patients will be premedicated with 0-2 mg midazolam per preference of the attending anesthesiologist. General anesthesia will be induced as preferred by the attending anesthesiologist, usually with a combination of lidocaine 1 mg/kg, propofol 1-4 mg/kg, fentanyl 1-2 µg/kg, and rocuronium 0.6-1.2 mg/kg or succinylcholine 1.5 mg/kg. The trachea will be intubated, and the lungs mechanically ventilated per clinical routine. General anesthesia will be maintained with an initial sevoflurane target concentration of 0.8% which will be adjusted based on apparent clinical need, supplemented with fentanyl. Vasopressors, antihypertensives, and drugs to control heart rate may be given as clinically indicated. BIS will be recorded to estimate hypnotic depth.
Patients will be randomized 1:1, stratified for chronic use of antihypertensive medication, in random-sized blocks to RI-guided fluid management or routine care. The randomization table will be prepared by trial statisticians, and allocation will be concealed until shortly before anesthetic induction with a web-based randomization system. The Zynex RI system will be applied and calibrated before anesthetic induction in all patients. A continuous fluid infusion of 1cc/ kg actual body weight/hour of crystalloid solution will be started in all patients before anesthesia induction and maintained until end of anesthesia. The trial groups will be:
Anesthesia will be maintained for the entire surgical procedure per clinical routine. At the end of the surgical procedure, patients will be extubated and transferred to the post anesthesia care unit (PACU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RI-Monitoring | The investigator will evaluate the feasibility of a RI-guided fluid ministration for improving perioperative characteristics. Feasibility will be defined by: The investigators will titrate fluid administration to maintain a RI > 90 over at least 85% of the intraoperative period lasting from induction until the end of anesthesia. Specifically, the investigator will consider titration to have been successful if 85% of patients in the RI group sustain a RI > 90 over at least 85% of the intraoperative period; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid | Other | The investigators will titrate fluid administration to maintain a RI > 90 over at least 85% of the intraoperative period lasting from induction until the end of anesthesia. Specifically, the investigator will consider titration to have been successful if 85% of patients in the RI group sustain a RI > 90 over at least 85% of the intraoperative period. |
| Measure | Description | Time Frame |
|---|---|---|
| Identify absolute and relative changes of RI | continuously monitor and obtain RI values throughout anesthesia and the post anesthesia care unit. | PACU stay |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients having major non-cardiac surgery expected to last ≥2 hours. The ASA physical status 1-3, and their age 21-85 years old. The patient should have a planned endotracheal intubation and general anesthesia with or without any regional blocks.
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Ruetzler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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