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

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ClinicalTrials.gov Identifier: NCT01186549

Recruitment Status : Completed

First Posted : August 23, 2010

Last Update Posted : October 11, 2012

Sponsor:

Information provided by (Responsible Party):

marzieh beigom khezri, Qazvin University Of Medical Sciences

Study Description

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

Condition or disease	Intervention/treatment	Phase
Pain Due to Propofol Injection Hemodynamic Changes Due to Propofol Injection	Drug: Ephedrine 30microgram/kg Drug: lidocaine0.5mg/kg -ephedrine30 micrograms/kg Drug: ephedrine 70 microgram/kg Drug: lidocaine 0.5mg/kg Drug: normal saline 2ml	Phase 1 Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	165 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
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 Start Date :	August 2010
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ephedrine Hydrochloride Lidocaine hydrochloride Pseudoephedrine Ephedrine sulfate Lidocaine Ephedrine Pseudoephedrine hydrochloride Propofol Pseudoephedrine sulfate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ephedrine 30 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	Drug: 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
Active Comparator: 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	Drug: 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
Active Comparator: 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	Drug: 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
Active Comparator: 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	Drug: 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
Placebo Comparator: 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	Drug: 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

mean arterial blood pressure [ Time Frame: 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 [ Time Frame: 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

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186549

Locations

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

Sponsors and Collaborators

Qazvin University Of Medical Sciences

More Information

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Responsible Party:	marzieh beigom khezri, Qazvine University Of Medical Sciences, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:	NCT01186549
Other Study ID Numbers:	ACTRN12610000610033 ACTRN12610000610033
First Posted:	August 23, 2010 Key Record Dates
Last Update Posted:	October 11, 2012
Last Verified:	October 2012

Keywords provided by marzieh beigom khezri, Qazvin University Of Medical Sciences:


propofol ephedrine pain

Additional relevant MeSH terms:

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Lidocaine Ephedrine Pseudoephedrine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers	Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Sympathomimetics Autonomic Agents Vasoconstrictor Agents Adrenergic Agents Neurotransmitter Agents Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Nasal Decongestants

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