Use of a Modified Propofol Emulsion in Adults

January 2, 2012 updated by: B. Braun Melsungen AG

Prospective, Monocentric Controlled, Randomized, Double-blind Study to Compare the Two Different Propofol Emulsions Regarding Tolerability and Injection Pain During the Induction of Anesthesia in Adults

The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia.

Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

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

  • Germany
    • Nordrhein-Westfalen
      • Leverkusen, Nordrhein-Westfalen, Germany, 51375
        • Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female adults, age ≥ 18 years and ≤ 80 years
  • Anesthetic risk classified as ASA I-III
  • Patients undergoing elective surgery under general anesthesia
  • Signed informed consent

Exclusion Criteria:

  • Simultaneous participation in another trial
  • Known or suspected drug abuse
  • Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other necessary co-medication
  • Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or centrally active analgesics)
  • Patients taking lipid lowering drugs
  • History of decompensated renal failure
  • History of severe hepatic dysfunction, hepatic cirrhosis
  • Angiographically confirmed CHD (coronary heart disease) or cerebral ischemia
  • History of convulsive disorders
  • Decompensated cardiac insufficiency
  • Hypovolemia
  • Increased intracranial pressure
  • Pregnancy (positive ß-HCG test) and lactation
  • Emergency situation
  • Patient who receives parenteral fat emulsion, e.g. intralipid
  • Patients incapable of giving consent personally
  • Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Modified propofol (Propofol 0.5%)
Drug: Propofol
Propofol (drug), intravenous, induction of anesthesia
Other Names:
  • Modified propofol
ACTIVE_COMPARATOR: 2
Propofol 1%
Drug: Propofol 1%
Propofol (drug), intravenous, induction of anesthesia
Other Names:
  • Propofol-Lipuro 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Expression of Pain During Injection
Time Frame: during first propofol bolus
during first propofol bolus

Secondary Outcome Measures

Outcome Measure
Time Frame
Further Assessment of Injection Pain
Time Frame: during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia
during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia

Collaborators and Investigators

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

Sponsor

B. Braun Melsungen AG

Investigators

  • Principal Investigator: Stefan Soltész, MD, PhD, Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2008

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (ESTIMATE)

June 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 2, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC-G-H-0705

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.

Clinical Trials on Anesthesia

Clinical Trials on Propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe