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

Baskent University

Status and phase: Unknown; Phase 4

Conditions: Arteriovenous Fistula

Treatments: Drug: Propofol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02447796

KA 15/60

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Propofol

Active Comparator group

Description:

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)

Treatment:

Drug: Propofol

Dexmedetomidine (DEX)

Active Comparator group

Description:

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)

Treatment:

Drug: Dexmedetomidine