Effect of Phenylephrine During Shoulder Arthroscopic Surgery

Inje University

Status: Completed

Conditions: Disorder of Shoulder; Anesthesia

Treatments: Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02585570

2015-096

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 3 patient groups

Low dose phenylephrine

Experimental group

Description:

phenylephrine 0.5 mcg/kg/min

Treatment:

Drug: Phenylephrine

High dose phenylephrine

Experimental group

Description:

phenylephrine 1.0 mcg/kg/min .

Treatment:

Drug: Phenylephrine

Normal saline

No Intervention group

Description:

normal saline for 5minutes