Vasopressin to Prevent Hypotension During Beach Chair Surgery

Rotator Cuff Tear Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687894
• Other study ID #: CNUH-2012-074
• Status: Completed
• Phase: N/A
• First received: September 8, 2012
• Last updated: February 23, 2017
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2012
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Joint Diseases
• Rotator Cuff Tear Arthropathy

Intervention

Drug:
• Vasopressins
Vasopressins propofol vasopressins sevoflurane
• Placebo
Placebo propofol & placebo sevoflurane
• propofol
vasopressin propofol & placebo propofol
• sevoflurane
vasopressins sevoflurane placebo sevoflurane

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine	Gwangju

Sponsors (2)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Chonnam National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral oxygen desaturation	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
Primary	The magnitude of decrease of mean arterial pressure	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	Jugular venous oxygen desaturation	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