Full Text View
Tabular View
No Study Results Posted
Related Studies
Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery
This study has been completed.
Study NCT00521612   Information provided by General Hospital Dubrovnik
First Received: August 27, 2007   Last Updated: December 26, 2007   History of Changes

August 27, 2007
December 26, 2007
September 2007
November 2007   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00521612 on ClinicalTrials.gov Archive Site
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 ]
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 ]
 
Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery
Prospective Randomised Controled Trial: Comparison of Volatile Anaesthetics Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery

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).

Two groups of patients are going to have abdominal surgery with low-flow general anaesthesia.

Group A (sevoflurane group, experimental group) Patients will receive midazolam for premedication 45 minutes before surgery. Dose is 0,08 mg/kg i.m. Patients will be preoxygenated with 100 % oxygen with oxygen flow of 7,5 L/min. When peripheral blood saturation reach 100 %, the induction of general anaesthesia will start. For induction patients will get anaesthetic thiopental 4,5 mg/kg i.v., analgetic fentanyl 3 mcg/kg i.v. and muscle relaxant vecuronium 0,1 mg/kg i.v. After 90 seconds patients will be intubated. After intubation anaesthetic gases will be switched on. Oxygen and nitrous oxide (50:50 %) and volatile anaesthetic sevoflurane 1 MAC (2,0 vol%). Patients will be ventilated by anaesthetic device. Intermittent positive pressure ventilation (IPPV) tidal volume 8 mL/kg, respiratory rate 12 times per minute, flow will be 1 L/min. 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. Signs that show the depth of anaesthesia are: arterial blood pressure (systolic, diastolic and mean), heart rate and bispectral index (BIS). Measuring points will be every 5 minutes during surgery. The goal is to provide the values of this vital signs within normal physiology ranges. Analgetic fentanyl will be repeated every 45 minutes in the dose of 0,8 mcg/kg i.v. Muscle relaxant vecuronium will be repeated in the dose of 0,5 mg/kg i.v. when train of four (TOF) shows score 30 % or higher. It will also be measured (every 5 minutes): inspiratory and expiratory concentration of sevoflurane, saturation of the blood with oxygen and level of end-tidal carbon dioxide. At the end of surgery, begins awakening from general anaesthesia. All anaesthetic gases will be switched off. Patients will be ventilated manually with 100 % oxygen with oxygen flow of 7,5 L/min. Every patient will get atropin 1 mg + neostigmine 2,5 mg i.v. for decurarization. Measuring points will be: start of awakening, extubation and discharge from operating theatre. It will be measured: arterial blood pressure (systolic, diastolic and mean), heart rate, inspiratory and expiratory concentration of sevoflurane, saturation of the blood with oxygen, level of end-tidal carbon dioxide, BIS and TOF. During surgery each patient will get i.v. infusion 2000 mL of sodium chloride 0.9 %.

Group B (isoflurane group, control group) Patients will receive midazolam for premedication 45 minutes before surgery. Dose is 0,08 mg/kg i.m. Patients will be preoxygenated with 100 % oxygen with oxygen flow of 7,5 L/min. When peripheral blood saturation reach 100 %, the induction of general anaesthesia will start. For induction patients will get anaesthetic thiopental 4,5 mg/kg i.v., analgetic fentanyl 3 mcg/kg i.v. and muscle relaxant vecuronium 0,1 mg/kg i.v. After 90 seconds patients will be intubated. After intubation anaesthetic gases will be switched on. Oxygen and nitrous oxide (50:50 %) and volatile anaesthetic isoflurane 1 MAC (1,2 vol%). Patients will be ventilated by anaesthetic device. Intermittent positive pressure ventilation (IPPV) tidal volume 8 mL/kg, respiratory rate 12 times per minute, flow will be 1 L/min. 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. Signs that show the depth of anaesthesia are: arterial blood pressure (systolic, diastolic and mean), heart rate and bispectral index (BIS). Measuring points will be every 5 minutes during surgery. The goal is to provide the values of this vital signs within normal physiology ranges. Analgetic fentanyl will be repeated every 45 minutes in the dose of 0,8 mcg/kg i.v. Muscle relaxant vecuronium will be repeated in the dose of 0,5 mg/kg i.v. when train of four (TOF) shows score 30 % or higher. It will also be measured (every 5 minutes): inspiratory and expiratory concentration of isoflurane, saturation of the blood with oxygen and level of end-tidal carbon dioxide. At the end of surgery, begins awakening from general anaesthesia. All anaesthetic gases will be switched off. Patients will be ventilated manually with 100 % oxygen with oxygen flow of 7,5 L/min. Every patient will get atropin 1 mg + neostigmine 2,5 mg i.v. for decurarization. Measuring points will be: start of awakening, extubation and discharge from operating theatre. It will be measured: arterial blood pressure (systolic, diastolic and mean), heart rate, inspiratory and expiratory concentration of isoflurane, saturation of the blood with oxygen, level of end-tidal carbon dioxide, BIS and TOF. During surgery each patient will get i.v. infusion 2000 mL of sodium chloride 0.9 %.

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).

 
Interventional
Other, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Anaesthesia
  • Drug: sevoflurane
  • Drug: isoflurane
  • Experimental: Sevoflurane group, experimental group
  • Active Comparator: Isoflurane group, control group

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
82
November 2007
November 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT00521612
Ante Crncevic, MD, MSc., General Hospital Dubrovnik
75736
General Hospital Dubrovnik
 
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
General Hospital Dubrovnik
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP