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Completed

NCT Number: NCT04671537

The Effects of Preloading Before Beach Chair Position

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Unıversity, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preloading with crystalloid fluid

Drug

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

Primary outcomes

  1. Mean arterial pressure

    Time frame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)

    (mmHg)

  2. Cardiac output

    Time frame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)

    (L/min)

  3. Stroke volume variation

    Time frame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)

    (%) data obtained from arterial contour analysis

  4. Heart rate

    Time frame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)

    bpm

Secondary outcomes

  1. Postoperative nausea and vomiting

    Time frame: in postoperative first day

    PONV rates

  2. Surgical satisfaction rate

    Time frame: in postoperative first day

    Surgical satisfaction scale (0-10, 0 lowest score, 10 highest score) (score)

  3. The duration of anesthesia and surgery

    Time frame: during surgery

    The duration of anesthesia and surgery (min)

  4. Ephedrine usage

    Time frame: during surgery

    total ephedrine dose (mg) used during surgery

  5. Total amount of crystalloid and colloid

    Time frame: during surgery

    Total amount of crystalloid and colloid (ml)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 17, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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