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Vasopressin to Prevent Hypotension During Beach Chair Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Chonnam National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Chonnam National University
Information provided by (Responsible Party):
Kyung Yeon Yoo, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01687894
First received: September 8, 2012
Last updated: September 15, 2012
Last verified: September 2012
  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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687894

Contacts
Contact: Hye J Jeong, M.D. 82-62-220-6893 ext 6895 pan79@hanmail.net
Contact: Kyung Y Yoo, M.D.,Ph.D. 82-62-220-6884 ext 6893 kyyoo@jnu.ac.kr

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine Recruiting
Gwangju, Korea, Republic of, 501-757
Contact: Young W Won    82-62-220-6893 ext 6895    ywwon@jnu.ac.kr   
Contact: Kyung Y Yoo, M.D.,Ph.D.    82-62-220-6884 ext 6895    kyyoo@jnu.ac.kr   
Principal Investigator: Kyung Y Yoo, M.D.,Ph.D.         
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

No publications provided

Responsible Party: Kyung Yeon Yoo, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01687894     History of Changes
Other Study ID Numbers: CNUH-2012-074
Study First Received: September 8, 2012
Last Updated: September 15, 2012
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases
Anesthetics
Anesthetics, Intravenous
Arginine Vasopressin
Propofol
Sevoflurane
Vasopressins
Anesthetics, General
Anesthetics, Inhalation
Antidiuretic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Coagulants
Hematologic Agents
Hemostatics
Hypnotics and Sedatives
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014