The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery

Study Overview
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Brief Summary
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Written informed consent must be obtained before any study specific procedures are undertaken. Informed consent will be obtained during pre-operative assessment.

Detailed Description
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The investigators will recruit 80 patients undergoing AV shunt surgery. All patients will receive general anesthesia and brachial plexus block. Patients will be randomly allocated into two groups. Study and control group received propofol target-controlled infusion (TCI) and inhaled anesthetics as anesthesia maintenance, respectively. Main outcomes will be assessed by perioperative blood pressure, heart rate, respiratory rate, end-tidal CO2, analgesics dosage, pain intensity and perioperative adverse events.

Official Title
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The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery

Conditions
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End Stage Renal Disease, Hemodialysis Complication

Intervention / Treatment
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* Drug: Propofol
* Device: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uremic adult(over20-year-old)patients under going arteriovenous (AV) shunt surgery Exclusion Criteria: one of below systemic diseases; chronic pulmonary, cardiac diseases(such as COPD, asthma, acute myoischemia), hepatic co-mobility(such as liver cirrhosis), morbid obesity, alcoholism, allergy to propofol and inhaled anesthetics, the women who are pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol group<br>propofol TCI plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml | Drug: Propofol<br>* Propofol works by increasing GABA-mediated inhibitory tone in the CNS. Propofol decreases the rate of dissociation of the GABA from the receptor, thereby increasing the duration of the GABA-activated opening of the chloride channel with resulting hyperpolarization of cell membranes.<br>|
| Active Comparator: Sevoflurane group<br>sevoflurane 2 4 % plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml | Device: Sevoflurane<br>* sevoflurane inhalation 2 4%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | Systolic blood pressure, diastolic blood pressure | The blood pressure change between baseline, post-induction 3mins, operation start, post-operation 10 mins,post-operation 30 mins,post-operation 1 hour,post-operation 2 hours, end of surgery, recovery room, up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesics dosage | post-operation analgesics dosage | The amount of analgesics dosage use at recovery room,an average of 4 hours | 
| Change in pain intensity | Visual Analog Score for pain | The pain intensity change at recovery room, post-operation day 1, post-operation day 2 |