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Sponsored by: |
General Hospital Dubrovnik |
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Information provided by: | General Hospital Dubrovnik |
ClinicalTrials.gov Identifier: | NCT00521612 |
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 |
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Anaesthesia |
Drug: sevoflurane Drug: isoflurane |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randomised Controled Trial: Comparison of Volatile Anaesthetics Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery |
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 |
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A: Experimental
Sevoflurane group, experimental group
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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.
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B: Active Comparator
Isoflurane group, control group
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Croatia | |
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: | General Hospital Dubrovnik ( Ante Crncevic, MD, MSc. ) |
Study ID Numbers: | 75736 |
Study First Received: | August 27, 2007 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00521612 |
Health Authority: | Croatia: Ministry of Health and Social Care |
sevoflurane isoflurane anaesthesia |
Isoflurane Sevoflurane |
Anesthetics, Inhalation Anesthetics, General Therapeutic Uses Hematologic Agents Physiological Effects of Drugs |
Central Nervous System Depressants Anesthetics Platelet Aggregation Inhibitors Central Nervous System Agents Pharmacologic Actions |