Dexmedetomidine and Propofol As Sole Sedative Agent for Patients Undergoing Arteriovenous Fistula Surgery

Phase 4

• Conditions: Arteriovenous Fistula
• Interventions: Drug: Propofol; Drug: Dexmedetomidine

• Registration Number: NCT02447796
• Lead Sponsor: Baskent University

Brief Summary

The investigators designed a prospective randomized study to compare the conventionally used sedative drug propofol with a latest alternative dexmedetomidine (DEX), in patients with end-stage renal disease undergoing arteriovenous fistula (AVF) surgery.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2015-05
• Study Start: 2015-05
• Primary Completion: 2015-05
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-18
• Last Update Submitted: 2015-05-18
• Study First Posted: 2015-05-19
• Last Update Posted: 2015-05-19
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Inclusion criteria were patients undergoing arteriovenous fistula (AVF) surgery aged between 20-70 with end stage renal failure on dialysis treatment.

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Exclusion Criteria

• Exclusion criteria were decompensated respiratory or heart failure, liver failure, obesity (body mass index>30), severe obstructive sleep apnea, need for additional different drugs for sedation, chronic use of alcohol, opioids or other sedative drugs,mental disorders, cognitive disorders, language problems and history of allergy to any medications used in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Propofol was administered at 1 mg/kg over a 10-min period followed by a continuous infusion at a rate of 1-1.5 mg/kg/h until the the begining of skin suture (n=24)
Dexmedetomidine (DEX)	Dexmedetomidine	DEX was administered at 1 μg/kg over a 10-min period followed by a continuous infusion at a rate of 1-1.5 μg/kg/h until the begining of skin suture (n=24)

Primary Outcome Measures

Name	Time	Method
The incidence of adverse effects such as respiratory and hemodynamic events	up to 24 hours postoperative

Secondary Outcome Measures

Name	Time	Method
The sedation onset time with using BIS and recovery times during the procedure.	up to 24 hours postoperative

Trial Locations

Locations (1)

Baskent University School of Medicine Adana Research and Teaching Center; 🇹🇷 Adana, Turkey