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

Qazvin University Of Medical Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pain Due to Propofol Injection; Hemodynamic Changes Due to Propofol Injection

Treatments: Drug: Ephedrine 30microgram/kg; Drug: ephedrine 70 microgram/kg; Drug: lidocaine0.5mg/kg -ephedrine30 micrograms/kg; Drug: lidocaine 0.5mg/kg; Drug: normal saline 2ml

Study type: Interventional

Funder types: Other

Identifiers

NCT01186549

ACTRN12610000610033

Details and patient eligibility

About

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

Enrollment: 165 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

165 participants in 5 patient groups, including a placebo group

ephedrine 30 microgram/kg

Active Comparator group

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

Treatment:

Drug: Ephedrine 30microgram/kg

ephedrine 70 microgram/kg

Active Comparator group

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

Treatment:

Drug: ephedrine 70 microgram/kg

lidocaine0.5mg/kg -ephedrine30 micrograms/kg

Active Comparator group

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

Treatment:

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

lidocaine 0.5mg/kg

Active Comparator group

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

Treatment:

Drug: lidocaine 0.5mg/kg

normal saline 2ml

Placebo Comparator group

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

Treatment:

Drug: normal saline 2ml