Trial intelligence / Profile preview

Ephedrine and Lidocaine Pretreatment for Propofol Injection Pain

NCT01186549Phase 2

Key facts

Status: Completed
Start: Aug 2010
Primary completion: Oct 2010
Countries: 1
Sponsor: Qazvin University of Medical Sciences
Modality: Small Molecules

Drugs: ephedrine
Conditions: painhypotension

Overview

Phase 2, randomised, double-blind trial of ephedrine in pain and hypotension (5 arms), sponsored by Qazvin University of Medical Sciences. Primary endpoint: Pain during propofol injection. Started Aug 2010; status: completed.

Design

5 arms

Study design: RandomizedDouble-blind

Ephedrine 30
Ephedrine 30 mcg/kg IV
Ephedrine 70
Ephedrine 70 mcg/kg IV
Lidocaine + Ephedrine
Lidocaine 0.5 mg/kg + Ephedrine 30 mcg/kg IV
Lidocaine
Lidocaine 0.5 mg/kg IV
Saline
Saline 2ml IV

Who it enrols

Adult patients (20-60 years) with ASA physical status I or II undergoing elective surgery. Patients with communication difficulties, history of allergic, neurologic, or cardiovascular disease, or recent analgesic use are excluded.

Endpoints

Primary

Pain during propofol injectionduring injection

Secondary

Mean Arterial Blood Pressure1 min post-intubation
Heart Rate1 min post-intubation

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