Vasopressin to Prevent Hypotension During Beach Chair Surgery

Completed

• Conditions: Rotator Cuff Tear Arthropathy
• Interventions: Drug: Vasopressins; Drug: Placebo; Drug: propofol; Drug: sevoflurane

• Registration Number: NCT01687894
• Lead Sponsor: Chonnam National University Hospital

Brief 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.

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 Timeline

• Study Start: 2012-05
• Status Verified: 2012-09
• Study First Submitted: 2012-09-08
• Study First Submitted QC: 2012-09-15
• Study First Posted: 2012-09-19
• Primary Completion: 2014-04
• Study Completion: 2014-12
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vasopressins & propofol	Vasopressins	Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.
Vasopressins & sevoflurane	Vasopressins	Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia
Placebo & sevoflurane	Placebo	Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia
Placebo & propofol	Placebo	Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia
Vasopressins & propofol	propofol	Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.
Placebo & propofol	propofol	Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia
Vasopressins & sevoflurane	sevoflurane	Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia
Placebo & sevoflurane	sevoflurane	Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia

Primary Outcome Measures

Name	Time	Method
The magnitude of decrease of mean arterial pressure	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

Name	Time	Method
Jugular venous oxygen desaturation	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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine; 🇰🇷 Gwangju, Korea, Republic of