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

Sponsor:	General Hospital Dubrovnik
Information provided by:	General Hospital Dubrovnik
ClinicalTrials.gov Identifier:	NCT00521612

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

Drug Information available for: Isoflurane Sevoflurane

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Web site of General Hospital Dubrovnik This link exits the ClinicalTrials.gov site

Publications:

Mahajan VA, Ni Chonghaile M, Bokhari SA, Harte BH, Flynn NM, Laffey JG. Recovery of older patients undergoing ambulatory anaesthesia with isoflurane or sevoflurane. Eur J Anaesthesiol. 2007 Jun;24(6):505-10. Epub 2007 Jan 4.

Venkatesh BG, Mehta Y, Kumar A, Trehan N. Comparison of sevoflurane and isoflurane in OPCAB surgery. Ann Card Anaesth. 2007 Jan;10(1):46-50.

Seitsonen ER, Yli-Hankala AM, Korttila KT. Similar recovery from bispectral index-titrated isoflurane and sevoflurane anesthesia after outpatient gynecological surgery. J Clin Anesth. 2006 Jun;18(4):272-9.

Sakai EM, Connolly LA, Klauck JA. Inhalation anesthesiology and volatile liquid anesthetics: focus on isoflurane, desflurane, and sevoflurane. Pharmacotherapy. 2005 Dec;25(12):1773-88. Review.

Nakayama M, Kanaya N, Edanaga M, Namiki A. Hemodynamic and bispectral index responses to tracheal intubation during isoflurane or sevoflurane anesthesia. J Anesth. 2003;17(4):223-6.

Responsible Party:	Ante Crncevic, MD, MSc., General Hospital Dubrovnik
ClinicalTrials.gov Identifier:	NCT00521612 History of Changes
Other Study ID Numbers:	75736
Study First Received:	August 27, 2007
Last Updated:	December 26, 2007
Health Authority:	Croatia: Ministry of Health and Social Care

Keywords provided by General Hospital Dubrovnik:

sevoflurane
isoflurane
anaesthesia

Additional relevant MeSH terms:

Anesthetics
Isoflurane
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on February 09, 2012