- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01186549
The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain and Hemodynamic Changes Due to Propofol Injection
Title: The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain Due to Propofol Injection in Patients Undergoing Elective Surgery Under General Anaesthesia
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
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Qazvin, Iran, Islamic Republic of, 34197/59811
- Qazvin university of medical science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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 |
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 |
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 |
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 |
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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
during the injection period of propofol(One minute after the administration of the test solution) before loss of consciousness
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
before the administration of the test solution , just before intubation(three minutes after atracurium injection), and one minute after intubation
|
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
|
before the administration of the test solution, just before intubation(three minutes after atracurium injection) , and one minute after intubation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Vasoconstrictor Agents
- Nasal Decongestants
- Lidocaine
- Ephedrine
- Pseudoephedrine
Other Study ID Numbers
- ACTRN12610000610033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain Due to Propofol Injection
-
KVG Medical College and HospitalUnknownPain | Intravenous Propofol Injection
-
Cairo UniversityRecruitingPain on Propofol Injection (POPI)Egypt
-
The University of Texas Health Science Center,...ZARS Pharma Inc.UnknownPain on Propofol IV InjectionUnited States
-
The University of Texas Health Science Center,...CompletedPain on IV Injection of Propofol.United States
-
Inonu UniversityCompletedPain on Injection of Propofol,Lidocaine, Alkalinized LidocaineTurkey
-
Sohag UniversityRecruitingPain, During Injection of Propofol for Induction of AnesthesiaEgypt
-
NYU Langone HealthRecruitingAnxiety Related to Pain Related to an Intraarticular Injection | Pain Related to an Intraarticular InjectionUnited States
-
Beni-Suef UniversityCompletedEffect of Patient Awareness on Incidence and Severity of Propofol Injection Induced PainEgypt
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Ain Shams UniversityCompletedPropofol Adverse Reaction | Injection Site ColdnessEgypt
Clinical Trials on Ephedrine 30microgram/kg
-
Hospices Civils de LyonCompletedInfant, Newborn | Intraoperative Arterial HypotensionFrance
-
Aswan UniversityCompletedCesarean Section Complications | Anesthesia | Subarachnoid BlockEgypt
-
Atridia Pty Ltd.Linear Clinical ResearchCompleted
-
Green Cross CorporationCompletedMucopolysaccharidosis IIKorea, Republic of
-
Genor Biopharma Co., Ltd.Unknown
-
Hangzhou Grand Biologic Pharmaceutical, Inc.Peking Union Medical College HospitalUnknownHealthy ParticipantsChina
-
Aileron Therapeutics, Inc.Completed
-
Imperial College LondonCompletedInfertilityUnited Kingdom
-
Shandong UniversityUnknownImage Quality | Skin DiscolorationChina
-
International AIDS Vaccine InitiativeBeth Israel Deaconess Medical Center; Ragon Institute of MGH, MIT and Harvard; University of Texas Health, Houston AIDS Research Team (HART) and other collaboratorsCompleted