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

Phase 1

Completed

• Conditions: End Stage Renal Disease; Hemodialysis Complication
• Interventions: Device: Sevoflurane; Drug: Propofol

• Registration Number: NCT03311581
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study Start: 2017-09-11
• Study First Submitted: 2017-09-17
• Study First Submitted QC: 2017-10-14
• Study First Posted: 2017-10-17
• Status Verified: 2020-05
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane group	Sevoflurane	sevoflurane 2\~4 % plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml
Propofol group	Propofol	propofol TCI plus brachial plexus block with ropivacaine 0.5% 30 to 40 ml

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan