ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT02229201
Date of registration:	11/08/2014
Prospective Registration:	No
Primary sponsor:	University Medical Centre Ljubljana
Public title:	Comparison of Two Anaesthetics on Brain During Brain Tumour Surgery
Scientific title:	Phase 1 Study of the Impact of Propofol vs. Sevoflurane on Brain Damage and Inflammatory Response During Brain Tumour Surgery
Date of first enrolment:	May 2010
Target sample size:	40
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT02229201
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Phase:	Phase 1

Countries of recruitment
Slovenia

Contacts

Name:	Jasmina Markovic Bozic, MD, MSC
Address:
Telephone:
Email:
Affiliation:	CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljan

Name:	Blaz Karpe, PHD
Address:
Telephone:
Email:
Affiliation:	Faculty of Natural Science and Engineering, University of Ljubljana

Name:	Iztok Potocnik, MD, MSC
Address:
Telephone:
Email:
Affiliation:	CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljan

Name:	Andrej Vranic, MD, PHD
Address:
Telephone:
Email:
Affiliation:	CD of Neurosurgery, University Medical Centre Ljubljana

Name:	Vesna Novak Jankovic, PROF, PHD
Address:
Telephone:
Email:
Affiliation:	CD of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana

Name:	Ales Jerin, PHD
Address:
Telephone:
Email:
Affiliation:	CLINICAL INSTITUTE OF CLINICAL CHEMISTRY AND BIOCHEMISTRY, University Medical Centre Ljubljana

Key inclusion & exclusion criteria

Inclusion Criteria:

- age 18-80 years

- American Society of Anaesthesiologists (ASA) physical status I-III

- Scheduled for brain tumour surgery

- Glasgow Coma Score 15

- Cooperative

Exclusion Criteria:

- No written informed consent

- Eendocrine systematic disease

- Ddrugs that alter endocrine metabolism

- History of drug hypersensitivity

- Drug addiction

- Perioperative blood derivatives.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Inflammation

Intervention(s)

Drug: Sevoflurane

Drug: Propofol

Primary Outcome(s)

Interleukin 10 plasma concentrations [Time Frame: Within 48 hours (1. Before surgery and anaesthesia 2. During surgery, 3. At the end of surgery 4.First postoperative day 5.Second postoperative day)]

Secondary Outcome(s)

Hospital stay [Time Frame: within the first 15 days after surgery]

Cardiovascular complications [Time Frame: within the first 15 days after surgery]

Death [Time Frame: within the first 15 days after surgery]

Change of blood pressure from the baseline [Time Frame: within the first 24 hours after surgery]

Pain using VAS score [Time Frame: within the first 24 hours after surgery]

Pulmonary complications [Time Frame: within the first 15 days after surgery]

Reoperation [Time Frame: within the first 15 days after surgery]

Neurological complications [Time Frame: within the first 15 days after surgery]

Postoperative nausea and vomiting (PONV) [Time Frame: within the first 24 hours after surgery]

Secondary ID(s)

UMCL-NKG-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.