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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2021-06-04

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.

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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.

Conditions

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End Stage Renal Disease Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Propofol group

propofol TCI plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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.

Sevoflurane group

sevoflurane 2\~4 % plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DEVICE

sevoflurane inhalation 2\~4%

Interventions

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Propofol

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.

Intervention Type DRUG

Sevoflurane

sevoflurane inhalation 2\~4%

Intervention Type DEVICE

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No