Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05536258 |
Other study ID # |
22-340 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 9, 2023 |
Est. completion date |
December 2024 |
Study information
Verified date |
April 2024 |
Source |
The Cleveland Clinic |
Contact |
Roberta Johnson |
Phone |
216-444-9950 |
Email |
johnsor13[@]ccf.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The trial groups will be:
1. Routine fluid management. Clinicians will be blinded to RI monitoring and use clinical
judgement to determine how much fluids should be given, and when. Clinical judgement
will be according to their standard practice and may include interpretation of blood
pressure, and heart rate.
2. RI-guided fluid administration. RI fluid guidance will be initiated before anesthesia
induction and will maintain until end of anesthesia. Clinicians will titrate fluids with
the goal of keeping RI above 90- always using good clinical judgement for individual
patients which may include avoiding fluid when RI is <90 or giving additional fluid when
RI >90. For RI scores below 90, 1 cc/kg actual body weight fluid bolus of any
crystalloid solution (normal saline or Ringer's lactate) will be given; colloids and
blood products can also be given if clinically indicated. The target will be maintained
until end of anesthesia.
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).
Description:
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:
1. Routine fluid management. Clinicians will be blinded to RI monitoring and use clinical
judgement to determine how much fluids should be given, and when. Clinical judgement
will be according to their standard practice and may include interpretation of blood
pressure, and heart rate.
2. RI-guided fluid administration. RI fluid guidance will be initiated before anesthesia
induction and will maintain until end of anesthesia. Clinicians will titrate fluids with
the goal of keeping RI above 90- always using good clinical judgement for individual
patients which may include avoiding fluid when RI is <90 or giving additional fluid when
RI >90. For RI scores below 90, 1 cc/kg actual body weight fluid bolus of any
crystalloid solution (normal saline or Ringer's lactate) will be given; colloids and
blood products can also be given if clinically indicated. The target will be maintained
until end of anesthesia.
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).