The Effects of Preloading Before Beach Chair Position

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT04671537

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Injuries Anesthesia Hemodynamic Instability	Drug: Preloading with crystalloid fluid	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study group - Control groupStudy group - Control group

Masking:

Single (Participant)

Masking Description:

Single-blind

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group (preloading with crystalloid fluid - isotonic solution) Preloading with crystalloid fluid (isotonic solution) at 10 ml/kg of ideal body weight	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
No Intervention: Control group (not preloading) no preloading

Arm

Intervention/Treatment

Experimental: Study group (preloading with crystalloid fluid - isotonic solution)

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

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

No Intervention: Control group (not preloading)

no preloading

Outcome Measures

Primary Outcome Measures

Mean arterial pressure [during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)]
(mmHg)
Cardiac output [during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)]
(L/min)
Stroke volume variation [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
Heart rate [during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)]
bpm

Secondary Outcome Measures

Postoperative nausea and vomiting [in postoperative first day]
PONV rates
Surgical satisfaction rate [in postoperative first day]
Surgical satisfaction scale (0-10, 0 lowest score, 10 highest score) (score)
The duration of anesthesia and surgery [during surgery]
The duration of anesthesia and surgery (min)
Ephedrine usage [during surgery]
total ephedrine dose (mg) used during surgery
Total amount of crystalloid and colloid [during surgery]
Total amount of crystalloid and colloid (ml)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Unıversity, Istanbul Faculty of Medicine	Istanbul		Turkey

Sponsors and Collaborators

Istanbul University

Investigators

Principal Investigator: Huru Ceren Gokduman, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Study Chair: Elif Aygun, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Principal Investigator: Nur Canbolat, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Study Director: Mert Canbaz, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Study Chair: Ali Ersen, MD, Istanbul Unıversity, Istanbul Faculty of Medicine Traumatology and Orthopedics
Study Chair: Mehmet Buget, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology