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The Effects of Preloading Before Beach Chair Position

Primary Purpose

Shoulder Injuries, Anesthesia, Hemodynamic Instability

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Preloading with crystalloid fluid
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Injuries focused on measuring beach chair position, arthroscopic shoulder surgery, preloading, hemodynamic stability, postoperative nausea and vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Istanbul Unıversity, Istanbul Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group (preloading with crystalloid fluid - isotonic solution)

Control group (not preloading)

Arm Description

Preloading with crystalloid fluid (isotonic solution) at 10 ml/kg of ideal body weight

no preloading

Outcomes

Primary Outcome Measures

Mean arterial pressure
(mmHg)
Cardiac output
(L/min)
Stroke volume variation
(%) data obtained from arterial contour analysis
Heart rate
bpm

Secondary Outcome Measures

Postoperative nausea and vomiting
PONV rates
Surgical satisfaction rate
Surgical satisfaction scale (0-10, 0 lowest score, 10 highest score) (score)
The duration of anesthesia and surgery
The duration of anesthesia and surgery (min)
Ephedrine usage
total ephedrine dose (mg) used during surgery
Total amount of crystalloid and colloid
Total amount of crystalloid and colloid (ml)

Full Information

First Posted
December 3, 2020
Last Updated
December 12, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04671537
Brief Title
The Effects of Preloading Before Beach Chair Position
Official Title
Effectiveness of Preloading Before Beach Chair Position on Patients Undergoing Arthroscopic Shoulder Surgery: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries, Anesthesia, Hemodynamic Instability
Keywords
beach chair position, arthroscopic shoulder surgery, preloading, hemodynamic stability, postoperative nausea and vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study group - Control group
Masking
Participant
Masking Description
Single-blind
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group (preloading with crystalloid fluid - isotonic solution)
Arm Type
Experimental
Arm Description
Preloading with crystalloid fluid (isotonic solution) at 10 ml/kg of ideal body weight
Arm Title
Control group (not preloading)
Arm Type
No Intervention
Arm Description
no preloading
Intervention Type
Drug
Intervention Name(s)
Preloading with crystalloid fluid
Intervention Description
crystalloid fluid at 10 ml/kg of ideal body weight was administered intravenously in 30 min before the BCP for patients
Primary Outcome Measure Information:
Title
Mean arterial pressure
Description
(mmHg)
Time Frame
during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Title
Cardiac output
Description
(L/min)
Time Frame
during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Title
Stroke volume variation
Description
(%) data obtained from arterial contour analysis
Time Frame
during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Title
Heart rate
Description
bpm
Time Frame
during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Description
PONV rates
Time Frame
in postoperative first day
Title
Surgical satisfaction rate
Description
Surgical satisfaction scale (0-10, 0 lowest score, 10 highest score) (score)
Time Frame
in postoperative first day
Title
The duration of anesthesia and surgery
Description
The duration of anesthesia and surgery (min)
Time Frame
during surgery
Title
Ephedrine usage
Description
total ephedrine dose (mg) used during surgery
Time Frame
during surgery
Title
Total amount of crystalloid and colloid
Description
Total amount of crystalloid and colloid (ml)
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huru Ceren Gokduman, MD
Organizational Affiliation
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elif Aygun, MD
Organizational Affiliation
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nur Canbolat, MD
Organizational Affiliation
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mert Canbaz, MD
Organizational Affiliation
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ali Ersen, MD
Organizational Affiliation
Istanbul Unıversity, Istanbul Faculty of Medicine Traumatology and Orthopedics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mehmet Buget, MD
Organizational Affiliation
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Unıversity, Istanbul Faculty of Medicine
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24904427
Citation
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.
Results Reference
background
PubMed Identifier
22290457
Citation
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.
Results Reference
background
PubMed Identifier
24472443
Citation
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.
Results Reference
background

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The Effects of Preloading Before Beach Chair Position

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