Intraoperative Hypotension
Conditions
Keywords
Intraoperative hypotension, Peripheral perfusion indexI, General anesthesia, Non-cardiac surgery
Brief summary
Intraoperative hypotension is closely related to the poor prognosis of surgery. The study is focused on the effectiveness of maintaining normal peripheral perfusion index (PPI) on time-weighted average of hypotension during anesthesia.
Detailed description
Intraoperative hypotension is closely related to the poor prognosis of surgery. Hypotension decreased blood flow perfusion of organs, which lead to dysfunction of multiple organs, especially increasing serious complications such as cardio-cerebrovascular events and acute renal injury within 30 days after surgery. The aim of this study is to establish a set of strategies that can effectively prevent and treat intraoperative hypotension, so as to alleviate possible harm to patients from perioperative hypotension. The study is focused on the effectiveness of maintaining normal peripheral perfusion index (PPI) on time-weighted average of hypotension during anesthesia. The lower target mean arterial pressure (MAP) was higher than 65 mmHg. MAP less than 65 mmHg was defined as intraoperative hypotension between induction and tracheal extubation.
Interventions
BEHAVIORALPPI guided strategies
For targeted MAP or lower, if PPI\<1, more fluid therapy. if PPI\>3, vasoconstriction therapy. For MAP\<65mmHg and 1\<=PPI\<3, test bolus of 250 ml crystalloid fluid.
BEHAVIORALEmpirical strategies
Fluid therapy or vasoconstriction depended on experiences of anesthetic staffs.
Sponsors
zhiqiang zhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
65 years and older ASA Physical Status 1-3 general anesthesia arterial catheterization procedures last more than 2 hours communicate normally in Mandarin
Exclusion criteria
abnormal Allen's test higher target than 65 mmHg history of diabetes vascular diseases arrhythmia cardiac function class II and above physical disability, unable to conduct PPI monitoring participated in other clinical studies in the past month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time-weighted average of hypotension (TWA)<65mmHg | Intraoperative (between anesthesia induction and tracheal extubation) | total area under MAP\<65 mmHg/surgery length |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative number of intraoperative hypotension episodes | Intraoperative (between anesthesia induction and tracheal extubation) | Cumulative number of MAP\<65mmHg and last at least for three minutes |
| Cumulative time of intraoperative hypotension period | Intraoperative (between anesthesia induction and tracheal extubation) | Cumulative time of MAP\<65mmHg |
| Proportion of time with hypotension | Intraoperative (between anesthesia induction and tracheal extubation) | Proportion of cumulative time of intraoperative hypotension period and the anesthesia time |
| time-weighted average of hypertension (TWA)>100mmHg | Intraoperative (between anesthesia induction and tracheal extubation) | total area under MAP\>100 mmHg/surgery length |
| Rate of hypotension after anesthesia induction | from anesthesia induction to 15 minutes after then | the number of participants of hypotension/ the number of each group |
| postoperative plasma concentration of lactic acid | 5 minutes before and 5 minutes after the end of surgery | Plasma concentration of lactic acid in the end of surgery |
| arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2) | 5 minutes before and 5 minutes after the end of surgery | PaO2/FiO2 |
| intraoperative urine output | Intraoperative (between anesthesia induction and tracheal extubation) | urine output during the surgery |
| the rate of acute kidney injury (AKI) | within 7 days after the end of surgery | the number of participants with AKI/ the number of each group |
| Cumulative number of intraoperative hypertension episodes | Intraoperative (between anesthesia induction and tracheal extubation) | Cumulative number of MAP\>100 mmHg and last at least for three minutes |
Countries
China
Contacts
Primary ContactZhiqiang Zhou, Dr.
Outcome results
None listed