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

Arteriovenous Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02447796
• Other study ID #: KA 15/60
• Status: Recruiting
• Phase: Phase 4
• First received: May 11, 2015
• Last updated: May 18, 2015
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: May 2015
• Source: Baskent University
• Contact: Ozlem Ozmete, MD
• Phone: +903223272727
• Email: ozlemyilma[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

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).
• 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).

Locations

Country	Name	City	State
Turkey	Baskent University School of Medicine Adana Research and Teaching Center	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse effects such as respiratory and hemodynamic events		up to 24 hours postoperative	No
Secondary	The sedation onset time with using BIS and recovery times during the procedure.		up to 24 hours postoperative	Yes