The Effects of Preloading Before Beach Chair Position

Study Overview
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Brief Summary
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The main objective of this study is whether preloading before positioning would be effective for less hemodynamic instability. The study also analyzes that patients with preloading will decrease postoperative nausea and vomiting, better surgical satisfaction and shortened the duration of surgery and anesthesia.

Detailed Description
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Keeping patients in normovolemic state and hemodynamically stable in anesthesia and intensive care practice are important goals of anesthesiologist. It is known that hypotension that develops after taking patients to the beach chair position has a negative effect on cerebral oxygenation. Aggressive fluid regimes using to prevent hypotension can cause glycocalyx damage, edema and organ dysfunction. Also hypertension seconday to vasopressor therapy can cause bleeding at the surgical site and impaired surgical visualization during the arthroscopic shoulder surgery. In the literature, there are studies examine whether the hypotension is the result of decreased cardiac output or decreased systemic resistance and what should be the optimal treatment , but as far as investigators know, there is no study about effects of preloading before the beach chair position on hemodynamic parameters.

Official Title
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Effectiveness of Preloading Before Beach Chair Position on Patients Undergoing Arthroscopic Shoulder Surgery: Randomized Controlled Trial

Conditions
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Hemodynamic Instability, Shoulder Injuries, Anesthesia

Intervention / Treatment
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* Drug: Preloading with crystalloid fluid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing elective arthroscopic shoulder surgery in the BCP, age older than 18 years and younger than 65 years, the American Society of Anesthesiologist (ASA) physical status of I or II, accepting the study protocol. Exclusion Criteria: preoperative arrhythmia, significant heart failure valvular heart disease, preexisting cerebrovascular disease, deciding to switch to open surgery, vasopressor infusion during the surgery, using angiotensin converting enzyme inhibitors (ACEI) orangiotensin receptor blockers (ARB) as antihypertensive medication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study group - Control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group (preloading with crystalloid fluid - isotonic solution)<br>Preloading with crystalloid fluid (isotonic solution) at 10 ml/kg of ideal body weight | Drug: Preloading with crystalloid fluid<br>* crystalloid fluid at 10 ml/kg of ideal body weight was administered intravenously in 30 min before the BCP for patients<br>|
| No Intervention: Control group (not preloading)<br>no preloading | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure | (mmHg) | during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min) | 
| Cardiac output | (L/min) | during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min) | 
| Stroke volume variation | (%) data obtained from arterial contour analysis | during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min) | 
| Heart rate | bpm | during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting | PONV rates | in postoperative first day | 
| Surgical satisfaction rate | Surgical satisfaction scale (0-10, 0 lowest score, 10 highest score) (score) | in postoperative first day | 
| The duration of anesthesia and surgery | The duration of anesthesia and surgery (min) | during surgery | 
| Ephedrine usage | total ephedrine dose (mg) used during surgery | during surgery | 
| Total amount of crystalloid and colloid | Total amount of crystalloid and colloid (ml) | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beach chair position, arthroscopic shoulder surgery, preloading, hemodynamic stability, postoperative nausea and vomiting