The Effects of Preloading Before Beach Chair Position

NCT04671537 | Completed

• 1 other identifier: 2018/166711
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Injuries; Anesthesia; Hemodynamic Instability

Keywords

beach chair position; arthroscopic shoulder surgery; preloading; hemodynamic stability; postoperative nausea and vomiting

Outcome Measures

Primary Outcomes (4)

• Mean arterial pressure

  (mmHg)

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

• Cardiac output

  (L/min)

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

• 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)

• Heart rate

  bpm

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

Secondary Outcomes (5)

• Postoperative nausea and vomiting

  in postoperative first day

• Surgical satisfaction rate

  in postoperative first day

• The duration of anesthesia and surgery

  during surgery

• Ephedrine usage

  during surgery

• Total amount of crystalloid and colloid

  during surgery

Study Arms (2)

Study group (preloading with crystalloid fluid - isotonic solution)

EXPERIMENTAL

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

Drug: Preloading with crystalloid fluid

Control group (not preloading)

NO INTERVENTION

no preloading

Interventions

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

Study group (preloading with crystalloid fluid - isotonic solution)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul Unıversity, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 24904427 BACKGROUND

• 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.

  PMID: 22290457 BACKGROUND

• 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.

  PMID: 24472443 BACKGROUND

MeSH Terms

Conditions

Shoulder Injuries; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Huru Ceren Gokduman, MD

  Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

  PRINCIPAL INVESTIGATOR

• Elif Aygun, MD

  Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

  STUDY CHAIR

• Nur Canbolat, MD

  Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

  PRINCIPAL INVESTIGATOR

• Mert Canbaz, MD

  Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

  STUDY DIRECTOR

• Ali Ersen, MD

  Istanbul Unıversity, Istanbul Faculty of Medicine Traumatology and Orthopedics

  STUDY CHAIR

• Mehmet Buget, MD

  Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator M.D.

Model Details: Study group - Control group

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 17, 2020
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: January 1, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)