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Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521612
First Posted: August 28, 2007
Last Update Posted: January 7, 2008
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.
Information provided by:
General Hospital Dubrovnik
  Purpose
Two groups of patients are going to have abdominal surgery with low-flow general anaesthesia. Group A (sevoflurane group, experimental group) will use volatile anaesthetic sevoflurane. Group B (isoflurane group, control group) will use volatile anaesthetic isoflurane. It will be observed differences between volatile anaesthetic sevoflurane and volatile anaesthetic isoflurane for providing low-flow general anaesthesia for abdominal surgery. Duration of this randomised controled trial will be approximately 2 months. Estimated sample size will be 82 persons (41 in sevoflurane group and 41 in isoflurane group).

Condition Intervention
Anaesthesia Drug: sevoflurane Drug: isoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by General Hospital Dubrovnik:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 82
Study Start Date: September 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Sevoflurane group, experimental group
Drug: sevoflurane
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
Drug: isoflurane
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

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Croatia
General Hospital Dubrovnik
Dubrovnik, Croatia, 20 000
Sponsors and Collaborators
General Hospital Dubrovnik
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Ante Crncevic, MD, MSc., General Hospital Dubrovnik
ClinicalTrials.gov Identifier: NCT00521612     History of Changes
Other Study ID Numbers: 75736
First Submitted: August 27, 2007
First Posted: August 28, 2007
Last Update Posted: January 7, 2008
Last Verified: December 2007

Keywords provided by General Hospital Dubrovnik:
sevoflurane
isoflurane
anaesthesia

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General