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Completed

NCT Number: NCT06104020

Effect of Liberal Versus Restrictive Intraoperative Fluid Therapy on Postoperative Pulmonary Complications and Hemodynamics in Patients Undergoing Shoulder Arthroscopic Surgery.

The primary aim of our study is to leverage lung ultrasound to assess and identify postoperative pulmonary complications following shoulder arthroscopic surgery and the implications of the used irrigation fluid.the investigators will further investigate the impact of intraoperative fluid management strategies on these Postoperative pulmonary complications and their effects on hemodynamics. By harnessing the potential of lung ultrasound in this context, we aspire to enhance both the diagnostic capabilities and overall safety of shoulder arthroscopic surgery, ultimately improving patient outcomes.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuit university

Asyut, Egypt

About this study

Shoulder arthroscopy, a minimally invasive surgical technique, has become a preferred method for addressing conditions like rotator cuff tears and recurrent joint instability due to its advantages, such as reduced post-operative pain and quicker rehabilitation. However, recent attention has shifted to potential complications, including issues related to irrigation fluid, patient positioning in the beach-chair posture, and anesthesia protocols. One key concern is the use of pressurized irrigation fluid, which, while essential for visualization, carries the risk of complications, including subcutaneous emphysema, pneumomediastinum, tension pneumothorax, air embolism, pulmonary edema, and atelectasis. These complications can have systemic effects, emphasizing the need for precise intraoperative fluid management.

Intraoperative fluid management strategies are a subject of continuous debate in the field of surgery, giving rise to three main strategies: 'liberal,' 'restricted,' and 'goal-directed' fluid therapy. These strategies vary in terms of the type of fluid used, timing of administration, and volume administered. While administering large volumes of fluids may improve organ perfusion, it may also increase the incidence of perioperative cardiopulmonary complications. Conversely, fluid restriction may reduce the length of hospital stay but increase the risk of postoperative acute kidney injury. Goal-directed therapy, which tailors fluid administration based on reproducible endpoints, has been associated with improved perioperative outcomes. The Bezold-Jarisch reflex is a cardiovascular reflex that can result in severe bradycardia and vasodilation when activated, especially in fasting patients with beach-chair position and other positions that lead to pooling of the blood in the lower limb and, in turn, lead to a decrease in venous return.

Understanding the intricate relationship between this reflex and intraoperative fluid management is paramount for improving patient safety and surgical outcomes. This reflex can be triggered by various factors, including rapid fluid administration and alterations in venous return, particularly in patients positioned in the beach chair posture.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for elective shoulder arthroscopic surgery.
  • Adults aged 18 years and above.
  • Capable of providing informed consent voluntarily.
  • No known allergies or sensitivities to substances commonly used in the surgical procedure or study.
  • Stable baseline hemodynamics during preoperative evaluation

Exclusion criteria

  • Patients scheduled for open shoulder surgery.
  • Medical Comorbidities:
  • Pulmonary diseases, including chronic pulmonary diseases or pulmonary edema.
  • Previous cardiac diseases such as heart failure, myocardial infarction (MI), hypertension, and known types of arrhythmia.
  • Severe Organ Disease: Severe liver or kidney disease.
  • Body mass index (BMI) ≥ 35 kg/m².
  • Abnormal coagulation function.
  • Pregnancy
  • Refusal to Participate or Patients who cannot provide informed consent due to cognitive impairment or other reasons.
  • Previous shoulder arthroscopy.

Treatment and study plan

Intraoperative fluid management stratigies.

Other

Regimens of different intraoperative fluid management The restrictive fluid group (RG) aims to achieve a net zero fluid balance and involves a 2 mL/kg bolus at anesthesia induction, followed by an intraoperative crystalloid infusion at a rate of 4 mL/kg/hr.

The other group of patients, the liberal group (LG), will receive a 10 ml/kg bolus at anesthesia induction,followed by an intraoperative crystalloid infusion at a rate of 8 ml/kg/hr.

Primary outcomes

  1. lung ultrasound score (LUS)

    Time frame: 1-One hour before the start of Surgery. 2-Two hours after the End of surgery.

    we will Identify postoperative pulmonary complications using the lung ultrasound score (LUS) following shoulder arthroscopic surgery to assess the implications of the used irrigation fluid and The intraoperative Fluid infusion

    • 0 = normal lung aeration,
    • 1 = moderate loss of aeration
    • 2 = severe loss of aeration
    • 3 = complete loss of lung aeration

Secondary outcomes

  1. Blood Pressure

    Time frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

    Measured in millimeters of Mercury (mm Hg).

  2. Heart Rate

    Time frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

    Measured in Beats per Minute (bpm).

  3. Oxygen Saturation

    Time frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

    Measured in Percentage (%).

  4. Vasopressor Used and Dose

    Time frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

    Measured in milligrams (mg).

  5. Interval for Repeated Dose of the Vasopressor.

    Time frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

    Measured in minutes.

  6. Duration of Action of used Vasopressor

    Time frame: Continuous recording every 15 minutes from the start of the operation until its end, assessed up to the completion of the surgical procedure.

    Measured in Minutes.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Liberal Versus Restrictive Intraoperative Fluid Therapy on Postoperative Pulmonary Complications and Hemodynamics in Patients Undergoing Shoulder Arthroscopic Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2023
Registry last updated
Sep 16, 2026

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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