The Effects of Preloading Before Beach Chair Position

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671537
• Other study ID #: 2018/166711
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: December 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Hemodynamic Instability
• Shoulder Injuries

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure	(mmHg)	during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Primary	Cardiac output	(L/min)	during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Primary	Stroke volume variation	(%) data obtained from arterial contour analysis	during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Primary	Heart rate	bpm	during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
Secondary	Postoperative nausea and vomiting	PONV rates	in postoperative first day
Secondary	Surgical satisfaction rate	Surgical satisfaction scale (0-10, 0 lowest score, 10 highest score) (score)	in postoperative first day
Secondary	The duration of anesthesia and surgery	The duration of anesthesia and surgery (min)	during surgery
Secondary	Ephedrine usage	total ephedrine dose (mg) used during surgery	during surgery
Secondary	Total amount of crystalloid and colloid	Total amount of crystalloid and colloid (ml)	during surgery