NCT00690495

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

September 22, 2011

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

June 2, 2008

Results QC Date

August 17, 2011

Last Update Submit

January 2, 2012

Conditions

Anesthesia

Keywords

AnesthesiaInductionPain

Outcome Measures

Primary Outcomes (1)

  • Incidence of Expression of Pain During Injection

    during first propofol bolus

Secondary Outcomes (1)

  • Further Assessment of Injection Pain

    during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia

Study Arms (2)

1

EXPERIMENTAL

Modified propofol (Propofol 0.5%)

Drug: Propofol

2

ACTIVE COMPARATOR

Propofol 1%

Drug: Propofol 1%

Interventions

PropofolDRUG

Propofol (drug), intravenous, induction of anesthesia

Also known as: Modified propofol
1
Propofol 1%DRUG

Propofol (drug), intravenous, induction of anesthesia

Also known as: Propofol-Lipuro 1%
2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

Leverkusen, North Rhine-Westphalia, 51375, Germany

Location

Related Publications (1)

  • Soltesz S, Diekmann M, Mitrenga-Theusinger A, Keilen M, Molter GP. Reduced pain on injection with a 0.5% propofol emulsion during induction of anesthesia. Eur J Anaesthesiol. 2012 Mar;29(3):162-3. doi: 10.1097/EJA.0b013e32834cfa7d. No abstract available.

    PMID: 22012178DERIVED

MeSH Terms

Conditions

Pain

Interventions

Propofol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Study manager
Organization
B.Braun Melsungen AG
studies@bbraun.com
+49 5661 71

Study Officials

  • Stefan Soltész, MD, PhD

    Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 4, 2008

Study Start

May 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 5, 2012

Results First Posted

September 22, 2011

Record last verified: 2012-01

Locations

DE(1)