Vasopressin to Prevent Hypotension During Beach Chair Surgery

NCT ID: NCT01687894

Last Updated: 2017-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotator Cuff Tear Arthropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vasopressins & propofol

Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.

Vasopressins

Intervention Type DRUG

Vasopressins propofol vasopressins sevoflurane

propofol

Intervention Type DRUG

vasopressin propofol \& placebo propofol

Placebo & propofol

Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia

Placebo

Intervention Type DRUG

Placebo propofol \& placebo sevoflurane

propofol

Intervention Type DRUG

vasopressin propofol \& placebo propofol

Vasopressins & sevoflurane

Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia

Vasopressins

Intervention Type DRUG

Vasopressins propofol vasopressins sevoflurane

sevoflurane

Intervention Type DRUG

vasopressins sevoflurane placebo sevoflurane

Placebo & sevoflurane

Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia

Placebo

Intervention Type DRUG

Placebo propofol \& placebo sevoflurane

sevoflurane

Intervention Type DRUG

vasopressins sevoflurane placebo sevoflurane

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vasopressins

Vasopressins propofol vasopressins sevoflurane

Intervention Type DRUG

Placebo

Placebo propofol \& placebo sevoflurane

Intervention Type DRUG

propofol

vasopressin propofol \& placebo propofol

Intervention Type DRUG

sevoflurane

vasopressins sevoflurane placebo sevoflurane

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Arginine vasopressin saline 10 ml as placebo Intravenous anesthetic general anesthetic

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chonnam National University

OTHER

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kyung Yeon Yoo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kyung Y Yoo, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesiology and Pain Medicine

Gwangju, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Jang EA, Song JA, Shin JY, Yoon JJ, Yoo KY, Jeong S. Background anaesthetic agents do not influence the impact of arginine vasopressin on haemodynamic states and cerebral oxygenation during shoulder surgery in the beach chair position: a prospective, single-blind study. BMC Anesthesiol. 2017 May 30;17(1):73. doi: 10.1186/s12871-017-0364-9.

Reference Type DERIVED
PMID: 28558702 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CNUH-2012-074

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Parameters of Cerebral Perfusion
NCT02806492 COMPLETED NA