Back to resultsDexmedetomidine and Propofol As Sole Sedative Agent for Patients Undergoing Arteriovenous Fistula Surgery
Primary Purpose
Arteriovenous Fistula
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Propofol
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Fistula focused on measuring (AVF), surgery
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria were patients undergoing arteriovenous fistula (AVF) surgery aged between 20-70 with end stage renal failure on dialysis treatment.
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.
Sites / Locations
- Baskent University School of Medicine Adana Research and Teaching CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Propofol
Dexmedetomidine (DEX)
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
The incidence of adverse effects such as respiratory and hemodynamic events
Secondary Outcome Measures
The sedation onset time with using BIS and recovery times during the procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02447796
Brief Title
Dexmedetomidine and Propofol As Sole Sedative Agent for Patients Undergoing Arteriovenous Fistula Surgery
Official Title
A Comparative Study of Dexmedetomidine and Propofol As Sole Sedative Agent for Patients With End-Stage Renal Disease Undergoing Arteriovenous Fistula Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula
Keywords
(AVF), surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Dexmedetomidine (DEX)
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Pofol
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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 Measure Information:
Title
The incidence of adverse effects such as respiratory and hemodynamic events
Time Frame
up to 24 hours postoperative
Secondary Outcome Measure Information:
Title
The sedation onset time with using BIS and recovery times during the procedure.
Time Frame
up to 24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria were patients undergoing arteriovenous fistula (AVF) surgery aged between 20-70 with end stage renal failure on dialysis treatment.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ozlem Ozmete, MD
Phone
+903223272727
Ext
2461
Email
ozlemyilma@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cagla Bali, MD
Phone
+905320613026
Email
caglaetike@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anis Aribogan, Prof md
Organizational Affiliation
Baskent University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baskent University School of Medicine Adana Research and Teaching Center
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozlem Ozmete, MD
Phone
+903223272727
Email
ozlemyilma@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Dexmedetomidine and Propofol As Sole Sedative Agent for Patients Undergoing Arteriovenous Fistula Surgery
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