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

May 18, 2015 updated by: Ozlem Ozmete, Baskent University

A Comparative Study of Dexmedetomidine and Propofol As Sole Sedative Agent for Patients With End-Stage Renal Disease Undergoing Arteriovenous Fistula Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Adana, Turkey, 01250
        • Recruiting
        • Baskent University School of Medicine Adana Research and Teaching Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Drug: 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).
Other Names:
  • Pofol
Active Comparator: Dexmedetomidine (DEX)
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)
Drug: 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).
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of adverse effects such as respiratory and hemodynamic events
Time Frame: up to 24 hours postoperative
up to 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
The sedation onset time with using BIS and recovery times during the procedure.
Time Frame: up to 24 hours postoperative
up to 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

  • Principal Investigator: Anis Aribogan, Prof md, Başkent University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA 15/60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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