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

Sponsors

Lead Sponsor: Qazvin University Of Medical Sciences

Source Qazvin University Of Medical Sciences
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 August 2010
Completion Date November 2010
Primary Completion Date October 2010
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
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ephedrine 30microgram/kg

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: lidocaine0.5mg/kg -ephedrine30 micrograms/kg

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: ephedrine 70 microgram/kg

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: lidocaine 0.5mg/kg

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: normal saline 2ml

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
Location Countries

Iran, Islamic Republic of

Verification Date

October 2012

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
Number Of Arms 5
Arm Group

Label: ephedrine 30 microgram/kg

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

Label: ephedrine 70 microgram/kg

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

Label: lidocaine0.5mg/kg -ephedrine30 micrograms/kg

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

Label: lidocaine 0.5mg/kg

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

Label: normal saline 2ml

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov