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Completed

NCT Number: NCT01687894

Vasopressin to Prevent Hypotension During Beach Chair Surgery

Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia. The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are evaluated during surgery in BCP.

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Key information

Conditions

Rotator Cuff Tear Arthropathy Arthritis Chondrocalcinosis Crystal Arthropathies Joint Diseases Musculoskeletal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Pain Medicine

Gwangju, 501-757, South Korea

About this study

Patients undergoing shoulder surgery in BCP under general anaesthesia are randomly allocated to receive i.v. normal saline (control group) or AVP 0.05 or 0.07 U kg-1 (AVP group, n = 15 each) 2 min before moving into BCP. Mean arterial pressure (MAP), heart rate (HR), jugular venous bulb oxygen saturation (SjvO2) and regional cerebral tissue oxygen saturation (SctO2) are measured before (pre-sitting in supine position) and after patients assumed BCP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

elective arthroscopic shoulder surgery under general anesthesia in beach chair position

Exclusion criteria

preexisting cerebrovascular diseases, history of orthostatic hypotension, age less than 18 yr, and the American Society of Anesthesiologists physical status IV or V

Treatment and study plan

Vasopressins

Drug

Vasopressins propofol vasopressins sevoflurane

Other names: Arginine vasopressin

Placebo

Drug

Placebo propofol & placebo sevoflurane

Other names: saline 10 ml as placebo

Propofol

Drug

vasopressin propofol & placebo propofol

Other names: Intravenous anesthetic

Sevoflurane

Drug

vasopressins sevoflurane placebo sevoflurane

Other names: general anesthetic

Primary outcomes

  1. The magnitude of decrease of mean arterial pressure

    Time frame: Baseline (before positioning) and lowest value within 10 min into beach chair position

    Continuously measure mean arterial blood pressure before and after position change. Calculate the magnitude of maximum decrease of mean arterial pressure from baseline

Secondary outcomes

  1. Jugular venous oxygen desaturation

    Time frame: Up to 30 min after the positioning

    Jugular venous oxygen saturation is continuously measured whether its saturation is decreased below 50% or/and 40% for longer than 5 min.

Other outcomes

  1. Cerebral oxygen desaturation

    Time frame: Up to 30 min after the position change

    Continuously observe near-infrared spectroscopy measured cerebral oxygenation before and after beach chair position whether oxygen saturation decrease more than 20% from pre-sitting values

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Collaborators

  • Chonnam National University

Registry information

Official study title

Clinical Trials of Vasopressin for Prevention of Hypotension During Shoulder Surgery in Beach Chair Position Under General Anesthesia

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2012
Registry last updated
Feb 27, 2017

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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