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

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by Qazvin University Of Medical Sciences:

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
is assessed by echocardiogram monitoring

Enrollment:	165
Study Start Date:	August 2010
Study Completion Date:	November 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186549

Locations

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

No publications provided

Responsible Party:	marzieh beigom khezri, Qazvine University Of Medical Sciences, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:	NCT01186549 History of Changes
Other Study ID Numbers:	ACTRN12610000610033, ACTRN12610000610033
Study First Received:	August 19, 2010
Last Updated:	October 10, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Qazvin University Of Medical Sciences:

propofol
ephedrine
pain

Additional relevant MeSH terms:

Ephedrine
Pseudoephedrine
Lidocaine
Propofol
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Respiratory System Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on June 17, 2013