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

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03311581

Collaborator

(none)

Enrollment

Location

Arms

44.7

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease Hemodialysis Complication	Drug: Propofol Device: Sevoflurane	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 11, 2017

Actual Primary Completion Date :

Jun 4, 2021

Actual Study Completion Date :

Jun 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propofol group propofol TCI plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml	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.
Active Comparator: Sevoflurane group sevoflurane 2~4 % plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml	Device: Sevoflurane sevoflurane inhalation 2~4%

Arm

Intervention/Treatment

Experimental: Propofol group

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

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.

Active Comparator: Sevoflurane group

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

Device: Sevoflurane

sevoflurane inhalation 2~4%

Outcome Measures

Primary Outcome Measures

Change in 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]
Systolic blood pressure, diastolic blood pressure

Secondary Outcome Measures

analgesics dosage [The amount of analgesics dosage use at recovery room,an average of 4 hours]
post-operation analgesics dosage
Change in pain intensity [The pain intensity change at recovery room, post-operation day 1, post-operation day 2]
Visual Analog Score for pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Medical University Hospital	Kaohsiung		Taiwan	807

Sponsors and Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kaohsiung Medical University Chung-Ho Memorial Hospital

ClinicalTrials.gov Identifier:

NCT03311581

Other Study ID Numbers:

KMUHIRB-F(II)-20170080

First Posted:

Oct 17, 2017

Last Update Posted:

Sep 5, 2021

Last Verified:

May 1, 2020

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

Additional relevant MeSH terms:

Kidney Failure, Chronic

Arteriovenous Fistula

Propofol

Sevoflurane

Study Results

No Results Posted as of Sep 5, 2021