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

Phase 1

Completed

• Conditions: Pain Due to Propofol Injection; Hemodynamic Changes Due to Propofol Injection
• Interventions: Drug: lidocaine 0.5mg/kg; Drug: Ephedrine 30microgram/kg; Drug: normal saline 2ml; Drug: ephedrine 70 microgram/kg; Drug: lidocaine0.5mg/kg -ephedrine30 micrograms/kg

• Registration Number: NCT01186549
• Lead Sponsor: Qazvin University Of Medical Sciences

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine 0.5mg/kg	lidocaine 0.5mg/kg	Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
ephedrine 30 microgram/kg	Ephedrine 30microgram/kg	Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
normal saline 2ml	normal saline 2ml	Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
ephedrine 70 microgram/kg	ephedrine 70 microgram/kg	Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
lidocaine0.5mg/kg -ephedrine30 micrograms/kg	lidocaine0.5mg/kg -ephedrine30 micrograms/kg	Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected

Primary Outcome Measures

Name	Time	Method
pain during propofol injection is assessed by face pain scale(FPS) and verbal rating scale(VRS)	during the injection period of propofol(One minute after the administration of the test solution) before loss of consciousness

Secondary Outcome Measures

Name	Time	Method
mean arterial blood pressure	before the administration of the test solution , just before intubation(three minutes after atracurium injection), and one minute after intubation	mean arterial blood pressure is assessed by nonivasive automatic blood pressure measurement
heart rate	before the administration of the test solution, just before intubation(three minutes after atracurium injection) , and one minute after intubation	is assessed by echocardiogram monitoring

Trial Locations

Locations (1)

Qazvin university of medical science; 🇮🇷 Qazvin, Iran, Islamic Republic of