The Effects of Preloading Before Beach Chair Position

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Injuries; Anesthesia; Hemodynamic Instability
• Intervention / Treatment: Drug: Preloading with crystalloid fluid

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Unıversity, Istanbul Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Huru Ceren Gokduman, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology; Study Chair: Elif Aygun, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology; Principal Investigator: Nur Canbolat, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology; Study Director: Mert Canbaz, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology; Study Chair: Ali Ersen, MD, Istanbul Unıversity, Istanbul Faculty of Medicine Traumatology and Orthopedics; Study Chair: Mehmet Buget, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Publications and helpful links

General Publications

• Larsen SL, Lyngeraa TS, Maschmann CP, Van Lieshout JJ, Pott FC. Cardiovascular consequence of reclining vs. sitting beach-chair body position for induction of anesthesia. Front Physiol. 2014 May 19;5:187. doi: 10.3389/fphys.2014.00187. eCollection 2014.
• Woodcock TE, Woodcock TM. Revised Starling equation and the glycocalyx model of transvascular fluid exchange: an improved paradigm for prescribing intravenous fluid therapy. Br J Anaesth. 2012 Mar;108(3):384-94. doi: 10.1093/bja/aer515. Epub 2012 Jan 29.
• Chamos C, Vele L, Hamilton M, Cecconi M. Less invasive methods of advanced hemodynamic monitoring: principles, devices, and their role in the perioperative hemodynamic optimization. Perioper Med (Lond). 2013 Sep 17;2(1):19. doi: 10.1186/2047-0525-2-19.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 12, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: postoperative nausea and vomiting; hemodynamic stability; arthroscopic shoulder surgery; beach chair position; preloading
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries
• Other Study ID Numbers: 2018/166711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No