NCT03311581

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease
• Hemodialysis Complication

Interventions

Type	Name	Description
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%

Timeline

• Start date: 2017-09-11
• Primary completion: 2021-06-04
• Completion: 2021-06-04
• First posted: 2017-10-17
• Last updated: 2021-09-05

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study
• FDA-regulated device study