Esmolol Pretreatment on Pain During Injection of Propofol

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01885364

Enrollment

120

Registered

2013-06-25

Start date

2015-06-30

Completion date

2015-12-31

Last updated

2016-02-08

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

Conditions

Pain

Keywords

esmolol, pain, propofol, remifentanil

Brief summary

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.

Detailed 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).

Interventions

DRUGNormal saline

intravenous injection with normal saline before injection of propofol

DRUGEsmolol

intravenous injection with remifentanil 0.5 mg/kg before injection of propofol

DRUGRemifentanil

intravenous injection with remifentanil 0.35 ug/kg before injection of propofol

DRUGpropofol

intravenous injection after pretreatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pain on injection of propofol	10 seconds after injection of 25% of the total calculated dose of propofol (2 mg/kg)	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 injection of propofol, pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).

Countries

South Korea

Outcome results

None listed

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