Esmolol Pretreatment on Pain During Injection of Propofol

February 4, 2016 updated by: Younghoon Jeon, Kyungpook National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo & propofol
Pretreatment with normal saline before injection of propofol
Drug: Normal saline
intravenous injection with normal saline before injection of propofol
Drug: propofol
intravenous injection after pretreatment
Other Names:
  • diprivan
EXPERIMENTAL: esmolol 0.05 mg/kg & propofol
Pretreatment with esmolol 0.05 mg/kg before injection of propofol
Drug: propofol
intravenous injection after pretreatment
Other Names:
  • diprivan
Drug: Esmolol
intravenous injection with remifentanil 0.5 mg/kg before injection of propofol
Other Names:
  • breviblock
EXPERIMENTAL: esmolol 1 mg/kg & propofol
Pretreatment with esmolol 1 mg/kg before injection of propofol
Drug: propofol
intravenous injection after pretreatment
Other Names:
  • diprivan
Drug: Esmolol
intravenous injection with remifentanil 0.5 mg/kg before injection of propofol
Other Names:
  • breviblock
ACTIVE_COMPARATOR: remifentanil 0.35 ug/kg & propofol
Pretreatment with remifentanil 0.35 ug/kg before injection of propofol
Drug: propofol
intravenous injection after pretreatment
Other Names:
  • diprivan
Drug: Remifentanil
intravenous injection with remifentanil 0.35 ug/kg before injection of propofol
Other Names:
  • ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 seconds after injection of 25% of the total calculated dose of propofol (2 mg/kg)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (ESTIMATE)

June 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUH 2013-05-003-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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