Vasopressin to Prevent Hypotension During Beach Chair Surgery

February 23, 2017 updated by: Kyung Yeon Yoo, Chonnam National University Hospital

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gwangju, Korea, Republic of, 501-757
        • Department of anesthesiology and pain medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing shoulder surgery in the beach chair position under the general anesthesia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vasopressins & propofol
Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.
Vasopressins propofol vasopressins sevoflurane
Other Names:
  • Arginine vasopressin
vasopressin propofol & placebo propofol
Other Names:
  • Intravenous anesthetic
Placebo & propofol
Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia
vasopressin propofol & placebo propofol
Other Names:
  • Intravenous anesthetic
Placebo propofol & placebo sevoflurane
Other Names:
  • saline 10 ml as placebo
Vasopressins & sevoflurane
Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia
Vasopressins propofol vasopressins sevoflurane
Other Names:
  • Arginine vasopressin
vasopressins sevoflurane placebo sevoflurane
Other Names:
  • general anesthetic
Placebo & sevoflurane
Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia
Placebo propofol & placebo sevoflurane
Other Names:
  • saline 10 ml as placebo
vasopressins sevoflurane placebo sevoflurane
Other Names:
  • general anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (before positioning) and lowest value within 10 min into beach chair position

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 30 min after the positioning

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 30 min after the position change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kyung Y Yoo, M.D.,Ph.D, Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 8, 2012

First Submitted That Met QC Criteria

September 15, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

September 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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