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Clinical Trials/NCT02447796
NCT02447796
Unknown
Phase 4

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

Baskent University1 site in 1 country48 target enrollmentMay 2015

Overview

Phase
Phase 4
Intervention
Propofol
Conditions
Arteriovenous Fistula
Sponsor
Baskent University
Enrollment
48
Locations
1
Primary Endpoint
The incidence of adverse effects such as respiratory and hemodynamic events
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
July 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ozlem Ozmete

Medical Doctor

Baskent University

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.

Arms & Interventions

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: Propofol

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)

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

The incidence of adverse effects such as respiratory and hemodynamic events

Time Frame: up to 24 hours postoperative

Secondary Outcomes

  • The sedation onset time with using BIS and recovery times during the procedure.(up to 24 hours postoperative)

Study Sites (1)

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