Effect of Phenylephrine During Shoulder Arthroscopic Surgery

Not Applicable

Completed

• Conditions: Disorder of Shoulder; Anesthesia
• Interventions: Drug: Phenylephrine

• Registration Number: NCT02585570
• Lead Sponsor: Inje University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-30
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose phenylephrine	Phenylephrine	phenylephrine 0.5 mcg/kg/min
High dose phenylephrine	Phenylephrine	phenylephrine 1.0 mcg/kg/min .

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	30 minutes	After being beach chair position during shoulder arthroscopic surgery. We measure the incidence of hypotension with invasive blood pressure (Arterial line catheterization).

Trial Locations

Locations (1)

Haeundae paik hospital, inje university; 🇰🇷 Busan, Korea, Republic of