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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
marzieh beigom khezri, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01186549
First received: August 19, 2010
Last updated: October 10, 2012
Last verified: October 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014