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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311581
• Other study ID #: KMUHIRB-F(II)-20170080
• Status: Completed
• Phase: Phase 1
• Start date: September 11, 2017
• Est. completion date: June 4, 2021

Study information

• Verified date: May 2020
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• End Stage Renal Disease
• Hemodialysis Complication
• Kidney Failure, Chronic

Intervention

Drug:
• 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.

Device:
• Sevoflurane
sevoflurane inhalation 2~4%

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	analgesics dosage	post-operation analgesics dosage	The amount of analgesics dosage use at recovery room,an average of 4 hours
Secondary	Change in pain intensity	Visual Analog Score for pain	The pain intensity change at recovery room, post-operation day 1, post-operation day 2