Anesthesia Induction, Hemodynamic Stability, Transcatheter Aortic Valve Replacement
Conditions
Brief summary
The purpose of this study is to evaluate whether the administration of 5 ml/kg of colloid solution prior to anesthesia induction, compared with 5 ml/kg of lactated Ringer's solution, can reduce hemodynamic fluctuations during the induction period (defined as the first 15 minutes after induction) in patients undergoing Transcatheter Aortic Valve Replacement (TAVR).
Interventions
5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection is administered by infusion pump over 15 minutes before anesthesia induction.
DRUGLactate Ringer's Solution
5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years; * Patients scheduled to undergo elective TAVR under general anesthesia;
Exclusion criteria
* Allergy to hydroxyethyl starch, its components, and/or sodium lactate Ringer's solution, or a history of colloidal allergy; * Severe cardiac dysfunction (ejection fraction\[EF\] \< 35%); * Severe renal dysfunction (creatinine \> 132 μg/L and/or requiring renal replacement therapy); * Morbid obesity (body mass index\[BMI\] \> 37.5 kg/m² or \> 32.5 kg/m² with metabolic diseases); * Severe hepatic dysfunction ; * Severe electrolyte disturbances ; * Patients with preoperative intracranial hypertension requiring dehydration therapy; * Expected postoperative hospital stay \< 24 hours; * Patients scheduled for multiple surgeries during this hospitalization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The area under curve (AUC) of the change in mean arterial pressure from baseline during the induction period. | induction period, at an average of 15 minutes | The AUC below baseline MAP is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX) where Sbaseline is the baseline MAP, Si is the MAP at minute i (i = 0.5, 1, 1.5…15), and ΔX is the time interval between measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-induction hemodynamic instability, defined as arterial pressure (MAP)< 65 mmHg or a decrease of more than 20% from baseline within 15 minutes after induction. | 15 minutes after induction | — |
| Intraoperative use of vasoactive drugs. | Intraoperative period, at an average of 2 hours | — |
| Sequential Organ Failure Assessment(SOFA )score on the first postoperative day | The first postoperative day, at 24 hours after surgery | SOFA score grades organ dysfunction from 0 (normal) to 4 (most abnormal) for six organ systems . The total score is the sum of all six sub-scores, ranging from 0 to 24 . The higher score means the worse organ function. |
| Length of hospital stay. | The duration of the patient's hospitalization after the initial surgery, at an average of 5 days. | — |
| Proportion of patients admitted to the intensive care unit (ICU) after surgery | During the postoperative period prior to discharge (at an average of 5 days) | — |
| In-hospital all-cause mortality | During the postoperative period prior to discharge (at an average of 5 days) | — |
| All-cause mortality within 30 days postoperatively | 30 days after surgery | — |
| Proportion of patients receiving renal replacement therapy during the 30-day postoperative observation period | 30 days after surgery | — |
Contacts
CONTACTZhihong Lu
STUDY_CHAIRHailong Dong
Air Force Medical University
Outcome results
None listed