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Effect of Phenylephrine During Shoulder Arthroscopic Surgery

NCT ID: NCT02585570

Last Updated: 2016-11-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-09-30

Brief Summary

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The purpose of this study is to determine whether phenylephrine infusion are effective in the prevention of hypotension after changing position to beach chair position during general anesthesia for shoulder arthroscopic surgery.

Investigators hypothesized that by increasing arterial blood pressure with phenylephrine infusion, incidence of hypotension would be decreased.

Detailed Description

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The beach chair position is associated with hypotension, risk of cerebral hypoperfusion, and cerebral injury. Sixty-six patients undergoing elective shoulder arthroscopic surgery are randomized to receive either phenylephrine low dose (0.5 mcg/kg/hr), phenylephrine high dose (1.0 mcg/kg/min), or normal saline 5 minute before being placed in the beach chair position.

General anesthesia is induced with propofol, remifentanil and rocuronium (0.6 mg/kg) and the trachea intubated. Anesthesia is maintained with sevoflurane and remifentanil targeting for a BIS value 40-60. After hemodynamic stabilization, patients received on infusion of either phenylephrine high dose (1.0 mcg/kg/min), phenylephrine low dose (0.5 mcg/kg/hr) or normal saline 5 minute before being placed in the beach chair position. Following 15 minutes of infusion study drugs, measurements of mean arterial blood pressure and cardiac function (stroke volume variation, stroke volume index, and cardiac index) using Vigileo/Flotrac system were made.

Conditions

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Disorder of Shoulder Anesthesia

Keywords

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shoulder phenylephrine hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low dose phenylephrine

phenylephrine 0.5 mcg/kg/min

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Patients is received phenylephrine 1.0 mcg/kg/min or 0.5 mcg/kg/min for 5 minutes before being placed in the beach chair position.

High dose phenylephrine

phenylephrine 1.0 mcg/kg/min .

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Patients is received phenylephrine 1.0 mcg/kg/min or 0.5 mcg/kg/min for 5 minutes before being placed in the beach chair position.

Normal saline

normal saline for 5minutes

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Phenylephrine

Patients is received phenylephrine 1.0 mcg/kg/min or 0.5 mcg/kg/min for 5 minutes before being placed in the beach chair position.

Intervention Type DRUG

Other Intervention Names

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Phenylephrine hydrochloride

Eligibility Criteria

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Inclusion Criteria

* shoulder arthroscopic surgery undergone beach chair position

Exclusion Criteria

* History of cerebrovascular event,
* significant cardiac disease (New York Heart Association symptoms class ≥ 3)
* uncontrolled hypertensive patients.
* American society of anesthesiologist class 4,5
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Ki Hwa Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ki Hwa Lee, M.D

Role: PRINCIPAL_INVESTIGATOR

Haeundae paik hospital, inje university

Locations

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Haeundae paik hospital, inje university

Busan, , South Korea

Site Status

Countries

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South Korea

References

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Soeding PF, Hoy S, Hoy G, Evans M, Royse CF. Effect of phenylephrine on the haemodynamic state and cerebral oxygen saturation during anaesthesia in the upright position. Br J Anaesth. 2013 Aug;111(2):229-34. doi: 10.1093/bja/aet024. Epub 2013 Mar 21.

Reference Type BACKGROUND
PMID: 23518801 (View on PubMed)

Other Identifiers

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2015-096

Identifier Type: -

Identifier Source: org_study_id