Title: The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain Due to Propofol Injection in Patients Undergoing Elective Surgery Under General Anaesthesia
The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain and Hemodynamic Changes Due to Propofol Injection
Sponsors
Source
Qazvin University Of Medical Sciences
Oversight Info
Has Dmc
No
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
Overall Status
Completed
Start Date
2010-08-01
Completion Date
2010-11-01
Primary Completion Date
2010-10-01
Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
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
Measure |
Time Frame |
|
mean arterial blood pressure |
before the administration of the test solution , just before intubation(three minutes after atracurium injection), and one minute after intubation |
|
heart rate |
before the administration of the test solution, just before intubation(three minutes after atracurium injection) , and one minute after intubation |
Enrollment
165
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
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
Arm Group Label
ephedrine 30 microgram/kg
Intervention Type
Drug
Intervention Name
Description
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
Arm Group Label
lidocaine0.5mg/kg -ephedrine30 micrograms/kg
Intervention Type
Drug
Intervention Name
Description
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
Arm Group Label
ephedrine 70 microgram/kg
Intervention Type
Drug
Intervention Name
Description
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
Arm Group Label
lidocaine 0.5mg/kg
Intervention Type
Drug
Intervention Name
Description
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
Arm Group Label
normal saline 2ml
Eligibility
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
Gender
All
Minimum Age
20 Years
Maximum Age
60 Years
Healthy Volunteers
No
Location
Facility |
|
Qazvin university of medical science Qazvin 34197/59811 Iran, Islamic Republic of |
Location Countries
Country
Iran, Islamic Republic of
Verification Date
2012-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Qazvin University Of Medical Sciences
Investigator Full Name
marzieh beigom khezri
Investigator Title
Qazvine University Of Medical Sciences
Keywords
Has Expanded Access
No
Secondary Id
ACTRN12610000610033
Number Of Arms
5
Intervention Browse
Mesh Term
Lidocaine
Ephedrine
Pseudoephedrine
Propofol
Arm Group
Arm Group Label
ephedrine 30 microgram/kg
Arm Group Type
Active Comparator
Description
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
Arm Group Label
ephedrine 70 microgram/kg
Arm Group Type
Active Comparator
Description
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
Arm Group Label
lidocaine0.5mg/kg -ephedrine30 micrograms/kg
Arm Group Type
Active Comparator
Description
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
Arm Group Label
lidocaine 0.5mg/kg
Arm Group Type
Active Comparator
Description
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
Arm Group Label
normal saline 2ml
Arm Group Type
Placebo Comparator
Description
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
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
August 19, 2010
Study First Submitted Qc
August 20, 2010
Study First Posted
August 23, 2010
Last Update Submitted
October 10, 2012
Last Update Submitted Qc
October 10, 2012
Last Update Posted
October 11, 2012
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.