The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00290108
• Date of registration: 09/02/2006
• Primary sponsor: Technische Universität München
• Public title: The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
• Scientific title: The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index
• Date of first enrolment: March 2003
• Target sample size: 99
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00290108
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Eberhard Kochs, MD

Key inclusion & exclusion criteria

Inclusion criteria:

- American Society of Anesthesiologists (ASA) physical status 1-3

- scheduled for elective surgery under general anesthesia.

Exclusion criteria:

- emergency surgery

- obesity

- indication for rapid sequence induction

- drugs that affect the central nervous system

- history of alcohol or drug abuse

- neurological or psychiatric diseases

- contraindications against the use of propofol



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Elective Surgery

Healthy

Intervention(s)

Drug: Propofol

Primary Outcome(s)

maximum hypnotic effect as indicated by the minimum BIS value.

Secondary Outcome(s)

BIS 30 seconds after LOC

BIS at LOC

BIS at LOL

time to BISmin

time to loss of consciousness

time to loss of eye lash reflex

Secondary ID(s)

257/99

Source(s) of Monetary Support

Please refer to primary and secondary sponsors