Esmolol Pretreatment on Pain During Injection of Propofol

K

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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