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Completed

NCT Number: NCT01885364

Esmolol Pretreatment on Pain During Injection of Propofol

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

intravenous injection with normal saline before injection of propofol

esmolol

Drug

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

Other names: breviblock

Remifentanil

Drug

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

Other names: ultiva

Propofol

Drug

intravenous injection after pretreatment

Other names: diprivan

Primary outcomes

  1. Pain on injection of propofol

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2013
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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