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

NCT03311581 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: KMUHIRB-F(II)-20170080
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

End Stage Renal Disease; Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• analgesics dosage

  The amount of analgesics dosage use at recovery room,an average of 4 hours

• Change in pain intensity

  The pain intensity change at recovery room, post-operation day 1, post-operation day 2

Study Arms (2)

Propofol group

EXPERIMENTAL

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

Drug: Propofol

Sevoflurane group

ACTIVE COMPARATOR

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

Device: Sevoflurane

Interventions

Propofol 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.

Propofol group

Sevoflurane DEVICE

sevoflurane inhalation 2\~4%

Sevoflurane group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Uremic adult(over20-year-old)patients under going arteriovenous (AV) shunt surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Propofol

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2017
• First Posted: October 17, 2017
• Study Start: September 11, 2017
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: September 5, 2021

Record last verified: 2020-05

Locations

TW (1)