Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00521612|
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : January 7, 2008
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Anaesthesia||Drug: sevoflurane Drug: isoflurane||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Prospective Randomised Controled Trial: Comparison of Volatile Anaesthetics Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
Sevoflurane group, experimental group
Volatile anaesthetic sevoflurane 1 MAC (2,0 vol%) will be administer to the patients in the form of gas (via respiration). First 20 minutes of anaesthesia will be period of saturation of the body with anaesthetic sevoflurane. After 20 minutes the depth of anaesthesia will be titrated with level of anaesthetic sevoflurane. Change will be +10 % of sevoflurane MAC (0,2 vol%) for every change of signs that indicate shallow anaesthesia. Change will be -10 % of sevoflurane MAC (0,2 vol%) for every change of signs that indicate too deep anaesthesia. Measuring points will be every 5 minutes during surgery.
Other Name: Sevorane
Active Comparator: B
Isoflurane group, control group
Volatile anaesthetic isoflurane 1 MAC (1,2 vol%) will be administer to the patients in the form of gas (via respiration). First 20 minutes of anaesthesia will be period of saturation of the body with anaesthetic isoflurane. After 20 minutes the depth of anaesthesia will be titrated with level of anaesthetic isoflurane. Change will be +10 % of isoflurane MAC (0,12 vol%) for every change of signs that indicate shallow anaesthesia. Change will be -10 % of isoflurane MAC (0,12 vol%) for every change of signs that indicate too deep anaesthesia. Measuring points will be every 5 minutes during surgery.
Other Name: Forane
- Differences between volatile anaesthetic sevoflurane and volatile anaesthetic isoflurane for providing low-flow general anaesthesia for abdominal surgery. [ Time Frame: approximately time for this trial is about 2 months ]
- Differences in awakening patients from low-flow general anaesthesia provided by sevoflurane and isoflurane. [ Time Frame: approximately time for this trial is about 2 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Every patient who is older than 18 years and who volunteer for this randomised controled trial and give written permission for participating in this study.
- Patients ASA I or ASA II.
- Only patients who need elective abdominal surgery (not urgent surgery).
- Patient body mass between 60 and 100 kg.
- Patients younger than 18 years
- Patients ASA III and higher
- Patients who need urgent abdominal surgery
- Patients allergic to anaesthetics
- Pregnant women
- Patients with neuromuscular diseases; and
- Persons with epidural analgesia catheter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521612
|General Hospital Dubrovnik|
|Dubrovnik, Croatia, 20 000|
|Principal Investigator:||Ante Crncevic, MD, MSc.||specialist in anaesthesiology and intensive care medicine|
|Study Chair:||Zoran Dogas, MD, PhD.||Professor of Neuroscience, University of Split, School of Medicine|
|Responsible Party:||Ante Crncevic, MD, MSc., General Hospital Dubrovnik|
|Other Study ID Numbers:||
|First Posted:||August 28, 2007 Key Record Dates|
|Last Update Posted:||January 7, 2008|
|Last Verified:||December 2007|
Platelet Aggregation Inhibitors
Central Nervous System Depressants
Physiological Effects of Drugs