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

NCT02447796 | Unknown Phase 4 DMC

• 1 other identifier: KA 15/60
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Fistula

Keywords

(AVF); surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse effects such as respiratory and hemodynamic events

  up to 24 hours postoperative

Secondary Outcomes (1)

• The sedation onset time with using BIS and recovery times during the procedure.

  up to 24 hours postoperative

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Dexmedetomidine (DEX)

ACTIVE COMPARATOR

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

Interventions

Propofol 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).

Also known as: Pofol

Propofol

Dexmedetomidine 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).

Also known as: Precedex

Dexmedetomidine (DEX)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University School of Medicine Adana Research and Teaching Center

Adana, 01250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anis Aribogan, Prof md

  Baskent University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozlem Ozmete, MD

CONTACT

+903223272727; ozlemyilma@yahoo.com

Cagla Bali, MD

CONTACT

+905320613026; caglaetike@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 19, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

TU (1)