Esmolol Pretreatment on Pain During Injection of Propofol

Kyungpook National University

Status: Completed

Conditions: Pain

Treatments: Drug: Esmolol; Drug: propofol; Drug: Normal saline; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01885364

KNUH 2013-05-003-001

Details and patient eligibility

About

Pain on injection of propofol is a common side effect. The present study was designed to investigate the effect of esmolol on pain on propofol injection and to compare it with remifentanil and placebo.

Full description

In a double-blind, prospective trial, 120 patients scheduled to undergo elective surgery were randomized to receive normal saline (n=30), remifentanil 0.35 μg/kg (n=30), esmolol 0.5 mg/kg (n=30), or Esmolol 1mg/kg (n=30) as pretreatment. Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after propofol had been given at the rate of 0.5 ml/sec pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).

Enrollment: 120 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged 19-60 years, American Society of Anesthesiologists (ASA) physical status I and II, scheduled for elective surgery under general anesthesia

Exclusion criteria

• Patients with cardiovascular, neurological or psychiatric disorder problem, patients who received the analgesic or sedative medications within the last 24 hours, and pregnancy were excluded

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Placebo & propofol

Placebo Comparator group

Description:

Pretreatment with normal saline before injection of propofol

Treatment:

Drug: Normal saline

Drug: propofol

esmolol 0.05 mg/kg & propofol

Experimental group

Description:

Pretreatment with esmolol 0.05 mg/kg before injection of propofol

Treatment:

Drug: propofol

Drug: Esmolol

esmolol 1 mg/kg & propofol

Experimental group

Description:

Pretreatment with esmolol 1 mg/kg before injection of propofol

Treatment:

Drug: propofol

Drug: Esmolol

remifentanil 0.35 ug/kg & propofol

Active Comparator group

Description:

Pretreatment with remifentanil 0.35 ug/kg before injection of propofol

Treatment:

Drug: Remifentanil

Drug: propofol