Norepinephrine and Phenylephrine, Which Better for Elderly?

NCT ID: NCT04067817

Last Updated: 2019-10-08

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-06

Study Completion Date

2020-01-30

Brief Summary

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this is a prospective, double-blinded and single-center study. this study is based on the Stroke volume variation fluid guided therapy, to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.

Detailed Description

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Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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norepinephrine

Blood pressure is generally maintained at value not less than 80% of baseline during intraoperative period. If the blood pressure is within normal range and SVV is less than 9, patient will be given a continuous infusion of crystalloid solution. However, when blood pressure drops and SVV is greater than 13, a bolus of 200mL colloid will then be quickly administered. If the blood pressure doesn't recover back to normal range within 5 minutes after bolus, norepinephrine will be given through the central venous catheter. If SVV is between 9 and 13, a bolus of crystalloid at 8mL/kg/h will be administered

Group Type EXPERIMENTAL

norepinephrine

Intervention Type DRUG

patient who was received the treatment of norepinephrine

phenylephrine

Blood pressure is generally maintained at value not less than 80% of baseline during intraoperative period. If the blood pressure is within normal range and SVV is less than 9, patient will be given a continuous infusion of crystalloid solution. However, when blood pressure drops and SVV is greater than 13, a bolus of 200mL colloid will then be quickly administered. If the blood pressure doesn't recover back to normal range within 5 minutes after bolus, phenylephrine will be given through the central venous catheter. If SVV is between 9 and 13, a bolus of crystalloid at 8mL/kg/h will be administered.

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

patient who was received the treatment of phenylephrine

Interventions

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norepinephrine

patient who was received the treatment of norepinephrine

Intervention Type DRUG

Phenylephrine

patient who was received the treatment of phenylephrine

Intervention Type DRUG

Other Intervention Names

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noradrenaline vasopressor vasopressor

Eligibility Criteria

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Inclusion Criteria

* radical resection of colorectal or gastric cancers,
* age over 65 years old,
* surgical time longer than 2hours,
* the American Society of Anesthesiologists(ASA) classification of II or III

Exclusion Criteria

* history of severe cardiovascular diseases,
* history of severe liver and kidney diseases,
* evidence of arrhythmia on EKG,
* use of positive end-expiratory pressure (PEEP) during mechanical ventilation;
* conditions with relative contraindication for arterial catheterization
Minimum Eligible Age

60 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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xiao z yang, MD,PhD

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Dalian Medical University

Locations

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The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xiao z yang, MD,PHD

Role: CONTACT

17709873399 ext. 0086

Facility Contacts

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yang z Xiao, MD,PhD

Role: primary

0866-17709873399

Other Identifiers

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poster2016

Identifier Type: -

Identifier Source: org_study_id

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