PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension

zhiqiang zhou54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Intraoperative Hypotension

Interventions

PPI guided strategiesBEHAVIORAL

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.

Empirical strategiesBEHAVIORAL

Fluid therapy or vasoconstriction depended on experiences of anesthetic staffs.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhiqiang Zhou

Wuhan, China

RECRUITING

Outcomes

Primary Outcomes

time-weighted average of hypotension (TWA)<65mmHg

total area under MAP\<65 mmHg/surgery length

Time frame: Intraoperative (between anesthesia induction and tracheal extubation)

Secondary Outcomes

Rate of hypotension after anesthesia induction

the number of participants of hypotension/ the number of each group

Time frame: from anesthesia induction to 15 minutes after then

Cumulative number of intraoperative hypotension episodes

Cumulative number of MAP\<65mmHg and last at least for three minutes

Time frame: Intraoperative (between anesthesia induction and tracheal extubation)

Cumulative time of intraoperative hypotension period

Cumulative time of MAP\<65mmHg

Time frame: Intraoperative (between anesthesia induction and tracheal extubation)

Proportion of time with hypotension

Proportion of cumulative time of intraoperative hypotension period and the anesthesia time

Time frame: Intraoperative (between anesthesia induction and tracheal extubation)

time-weighted average of hypertension (TWA)>100mmHg

total area under MAP\>100 mmHg/surgery length

Time frame: Intraoperative (between anesthesia induction and tracheal extubation)

Cumulative number of intraoperative hypertension episodes

Cumulative number of MAP\>100 mmHg and last at least for three minutes

Time frame: Intraoperative (between anesthesia induction and tracheal extubation)

Central Contacts

Zhiqiang Zhou, Dr.

CONTACT

862783663173 zqzhou@tjh.tjmu.edu.cn

Data from ClinicalTrials.gov

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