PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intraoperative Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PPI guided strategies

The decision making for prevention and treatment of hypotension was PPI guided to maintain the PPI between 1 and 3.

Group Type EXPERIMENTAL

PPI guided strategies

Intervention Type BEHAVIORAL

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.

conventional strategies

The decision making for prevention and treatment of hypotension dependent on the experience of anesthesiologist.

Group Type OTHER

Empirical strategies

Intervention Type BEHAVIORAL

Fluid therapy or vasoconstriction depended on experiences of anesthetic staffs.

Interventions

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PPI 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.

Intervention Type BEHAVIORAL

Empirical strategies

Fluid therapy or vasoconstriction depended on experiences of anesthetic staffs.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No