The Effects of Preloading Before Beach Chair Position

NCT ID: NCT04671537

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-01-01

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.

Conditions

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Shoulder Injuries Anesthesia Hemodynamic Instability

Keywords

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beach chair position arthroscopic shoulder surgery preloading hemodynamic stability postoperative nausea and vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study group - Control group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single-blind

Study Groups

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Study group (preloading with crystalloid fluid - isotonic solution)

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

Group Type EXPERIMENTAL

Preloading with crystalloid fluid

Intervention Type DRUG

crystalloid fluid at 10 ml/kg of ideal body weight was administered intravenously in 30 min before the BCP for patients

Control group (not preloading)

no preloading

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Nur Canbolat

Principal Investigator M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huru Ceren Gokduman, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Elif Aygun, MD

Role: STUDY_CHAIR

Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Nur Canbolat, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Mert Canbaz, MD

Role: STUDY_DIRECTOR

Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Ali Ersen, MD

Role: STUDY_CHAIR

Istanbul Unıversity, Istanbul Faculty of Medicine Traumatology and Orthopedics

Mehmet Buget, MD

Role: STUDY_CHAIR

Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Locations

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Istanbul Unıversity, Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 24904427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22290457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24472443 (View on PubMed)

Other Identifiers

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2018/166711

Identifier Type: -

Identifier Source: org_study_id