Vasopressin to Prevent Hypotension During Beach Chair Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rotator Cuff Tear Arthropathy

Intervention / Treatment
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* Drug: Vasopressins
* Drug: Placebo
* Drug: propofol
* Drug: sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vasopressins & propofol<br>Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia. | Drug: Vasopressins<br>* Vasopressins propofol vasopressins sevoflurane<br>* Other names: Arginine vasopressin;Drug: propofol<br>* vasopressin propofol & placebo propofol<br>* Other names: Intravenous anesthetic;|
| Placebo & propofol<br>Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia | Drug: Placebo<br>* Placebo propofol & placebo sevoflurane<br>* Other names: saline 10 ml as placebo;Drug: propofol<br>* vasopressin propofol & placebo propofol<br>* Other names: Intravenous anesthetic;|
| Vasopressins & sevoflurane<br>Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia | Drug: Vasopressins<br>* Vasopressins propofol vasopressins sevoflurane<br>* Other names: Arginine vasopressin;Drug: sevoflurane<br>* vasopressins sevoflurane placebo sevoflurane<br>* Other names: general anesthetic;|
| Placebo & sevoflurane<br>Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia | Drug: Placebo<br>* Placebo propofol & placebo sevoflurane<br>* Other names: saline 10 ml as placebo;Drug: sevoflurane<br>* vasopressins sevoflurane placebo sevoflurane<br>* Other names: general anesthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral oxygen saturation, beach chair position, hemodynamic, jugular venous oximetry