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The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain and Hemodynamic Changes Due to Propofol Injection

Information source: Qazvin University Of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain Due to Propofol Injection; Hemodynamic Changes Due to Propofol Injection

Intervention: Ephedrine 30microgram/kg (Drug); lidocaine0.5mg/kg -ephedrine30 micrograms/kg (Drug); ephedrine 70 microgram/kg (Drug); lidocaine 0.5mg/kg (Drug); normal saline 2ml (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Qazvin University Of Medical Sciences

Summary

Objectives: Injection pain and hypotension are two main adverse effects of propofol which distresses patient. The aim of this prospective double blind study was to compare the effect

of ephedrine - lidocaine combination with lidocaine and ephedrine on injection pain and

hemodynamic changes due to propofol induction. Methods: 165 adult patients, aged 20 to 60 yr, Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0. 5 mg/kg(L) ,ephedrine 30microgram/kg (E30),

ephedrine 70 microgram/kg(E70), lidocaine 0. 5mg/kg - ephedrine 30 microgram/kg(LE) or 2ml

saline (S) intravenously. After one minute propofol 2 mg/kg into a dorsal hand vein was injected. Face pain scale and verbal rating scale, arterial blood pressure and heart rate were recorded before induction, just before intubation, and one minute after intubation

Clinical Details

Official title: Title: The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain Due to Propofol Injection in Patients Undergoing Elective Surgery Under General Anaesthesia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: pain during propofol injection is assessed by face pain scale(FPS) and verbal rating scale(VRS)

Secondary outcome:

mean arterial blood pressure

heart rate

Eligibility

Minimum age: 20 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients with American Society of Anesthesiologists(ASA)physical statusIandII

Exclusion Criteria:

- patients with difficulty in communication

- history of allergic, neurologic or cardiovascular disease

- patients who had received an analgesic medication within 24 hr before surgery

Locations and Contacts

Qazvin university of medical science, Qazvin 34197/59811, Iran, Islamic Republic of
Additional Information

Starting date: August 2010
Last updated: October 10, 2012

Page last updated: August 20, 2015

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