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 Title of Study: “Effect of Phenylephrine Infusion for Preventing Hypotension During Shoulder Arthroscopic Surgery in the Beach Chair Position”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: September 2016
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.
- Drug: 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.
Arms, Groups and Cohorts
- Experimental: Low dose phenylephrine
- phenylephrine 0.5 mcg/kg/min
- Experimental: High dose phenylephrine
- phenylephrine 1.0 mcg/kg/min .
- No Intervention: Normal saline
- normal saline for 5minutes
Clinical Trial Outcome Measures
- Incidence of hypotension
- Time Frame: 30 minutes
- After being beach chair position during shoulder arthroscopic surgery. We measure the incidence of hypotension with invasive blood pressure (Arterial line catheterization).
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Inje University
- Provider of Information About this Clinical Study
- Principal Investigator: Ki Hwa Lee, Assistant professor – Inje University
- Overall Official(s)
- Ki Hwa Lee, M.D, Principal Investigator, Haeundae paik hospital, inje university
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.
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