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Vasopressin to Prevent Hypotension During Beach Chair Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01687894
First Posted: September 19, 2012
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chonnam National University
Information provided by (Responsible Party):
Kyung Yeon Yoo, Chonnam National University Hospital
  Purpose
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.

Condition Intervention
Rotator Cuff Tear Arthropathy Drug: Vasopressins Drug: Placebo Drug: propofol Drug: sevoflurane

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Trials of Vasopressin for Prevention of Hypotension During Shoulder Surgery in Beach Chair Position Under General Anesthesia

Resource links provided by NLM:


Further study details as provided by Kyung Yeon Yoo, Chonnam National University Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 74
Study Start Date: May 2012
Study Completion Date: December 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Vasopressins & propofol
Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.
Drug: Vasopressins
Vasopressins propofol vasopressins sevoflurane
Other Name: Arginine vasopressin
Drug: propofol
vasopressin propofol & placebo propofol
Other Name: Intravenous anesthetic
Placebo & propofol
Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia
Drug: Placebo
Placebo propofol & placebo sevoflurane
Other Name: saline 10 ml as placebo
Drug: propofol
vasopressin propofol & placebo propofol
Other Name: Intravenous anesthetic
Vasopressins & sevoflurane
Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia
Drug: Vasopressins
Vasopressins propofol vasopressins sevoflurane
Other Name: Arginine vasopressin
Drug: sevoflurane
vasopressins sevoflurane placebo sevoflurane
Other Name: general anesthetic
Placebo & sevoflurane
Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia
Drug: Placebo
Placebo propofol & placebo sevoflurane
Other Name: saline 10 ml as placebo
Drug: sevoflurane
vasopressins sevoflurane placebo sevoflurane
Other Name: general anesthetic

Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing shoulder surgery in the beach chair position under the general anesthesia
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687894


Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine
Gwangju, Korea, Republic of, 501-757
Sponsors and Collaborators
Chonnam National University Hospital
Chonnam National University
Investigators
Principal Investigator: Kyung Y Yoo, M.D.,Ph.D Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital
  More Information

Responsible Party: Kyung Yeon Yoo, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01687894     History of Changes
Other Study ID Numbers: CNUH-2012-074
First Submitted: September 8, 2012
First Posted: September 19, 2012
Last Update Posted: February 27, 2017
Last Verified: September 2012

Keywords provided by Kyung Yeon Yoo, Chonnam National University Hospital:
cerebral oxygen saturation
beach chair position
hemodynamic
jugular venous oximetry

Additional relevant MeSH terms:
Hypotension
Rotator Cuff Injuries
Joint Diseases
Rotator Cuff Tear Arthropathy
Vascular Diseases
Cardiovascular Diseases
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Musculoskeletal Diseases
Chondrocalcinosis
Arthritis
Crystal Arthropathies
Propofol
Anesthetics, Intravenous
Anesthetics
Sevoflurane
Vasopressins
Arginine Vasopressin
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents