Back to resultsThe Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery
Primary Purpose
End Stage Renal Disease, Hemodialysis Complication
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
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
Sites / Locations
- Kaohsiung Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Propofol group
Sevoflurane group
Arm Description
propofol TCI plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml
sevoflurane 2~4 % plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml
Outcomes
Primary Outcome Measures
Change in blood pressure
Systolic blood pressure, diastolic blood pressure
Secondary Outcome Measures
analgesics dosage
post-operation analgesics dosage
Change in pain intensity
Visual Analog Score for pain
Full Information
NCT ID
NCT03311581
First Posted
September 17, 2017
Last Updated
August 31, 2021
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03311581
Brief Title
The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery
Official Title
The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
June 4, 2021 (Actual)
Study Completion Date
June 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Written informed consent must be obtained before any study specific procedures are undertaken. Informed consent will be obtained during pre-operative assessment.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hemodialysis Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol group
Arm Type
Experimental
Arm Description
propofol TCI plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml
Arm Title
Sevoflurane group
Arm Type
Active Comparator
Arm Description
sevoflurane 2~4 % plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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
Device
Intervention Name(s)
Sevoflurane
Intervention Description
sevoflurane inhalation 2~4%
Primary Outcome Measure Information:
Title
Change in blood pressure
Description
Systolic blood pressure, diastolic blood pressure
Time Frame
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 Measure Information:
Title
analgesics dosage
Description
post-operation analgesics dosage
Time Frame
The amount of analgesics dosage use at recovery room,an average of 4 hours
Title
Change in pain intensity
Description
Visual Analog Score for pain
Time Frame
The pain intensity change at recovery room, post-operation day 1, post-operation day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery
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