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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01186549
Enrollment
165
Registered
2010-08-23
Start date
2010-08-31
Completion date
2010-11-30
Last updated
2012-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Changes Due to Propofol Injection, Pain Due to Propofol Injection

Keywords

propofol, ephedrine, pain

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

Interventions

DRUGEphedrine 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

DRUGlidocaine0.5mg/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

DRUGephedrine 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

DRUGlidocaine 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

Sponsors

Qazvin University Of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
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

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
mean arterial blood pressurebefore the administration of the test solution , just before intubation(three minutes after atracurium injection), and one minute after intubationmean arterial blood pressure is assessed by nonivasive automatic blood pressure measurement
heart ratebefore the administration of the test solution, just before intubation(three minutes after atracurium injection) , and one minute after intubationis assessed by echocardiogram monitoring

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026