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

NCT ID: NCT02447796

Last Updated: 2015-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Arteriovenous Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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)

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)

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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Pofol Precedex

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Ozlem Ozmete

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anis Aribogan, Prof md

Role: PRINCIPAL_INVESTIGATOR

Baskent University School of Medicine

Locations

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Baskent University School of Medicine Adana Research and Teaching Center

Adana, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ozlem Ozmete, MD

Role: CONTACT

+903223272727 ext. 2461

Cagla Bali, MD

Role: CONTACT

+905320613026

Facility Contacts

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Ozlem Ozmete, MD

Role: primary

+903223272727

Other Identifiers

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KA 15/60

Identifier Type: -

Identifier Source: org_study_id

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