Clinical trial NCT04671537: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Injuries
Anesthesia
Hemodynamic Instability
Keywords: beach chair position
arthroscopic shoulder surgery
preloading
hemodynamic stability
postoperative nausea and vomiting
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study group - Control group
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean arterial pressure
timeFrame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
measure: Cardiac output
timeFrame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
measure: Stroke volume variation
timeFrame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
measure: Heart rate
timeFrame: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Secondary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: in postoperative first day
measure: Surgical satisfaction rate
timeFrame: in postoperative first day
measure: The duration of anesthesia and surgery
timeFrame: during surgery
measure: Ephedrine usage
timeFrame: during surgery
measure: Total amount of crystalloid and colloid
timeFrame: during surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Unıversity, Istanbul Faculty of Medicine
Study officials:
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
name: Huru Ceren Gokduman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
name: Elif Aygun, MD
role: STUDY_CHAIR
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
name: Nur Canbolat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
name: Mert Canbaz, MD
role: STUDY_DIRECTOR
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine Traumatology and Orthopedics
name: Ali Ersen, MD
role: STUDY_CHAIR
affiliation: Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
name: Mehmet Buget, MD
role: STUDY_CHAIR
References:
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.
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.
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.