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
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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 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 |

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 |
- 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 ]
- 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

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

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
Iran, Islamic Republic of | |
Qazvin university of medical science | |
Qazvin, Iran, Islamic Republic of, 34197/59811 |
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 |
propofol ephedrine pain |
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 |