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.
First Received: August 27, 2007   Last Updated: December 26, 2007   History of Changes
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: 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

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 ] [ 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
A: Experimental
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.
B: Active Comparator
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.

  Hide Detailed Description

Detailed Description:

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).

  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:
Publications:
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     History of Changes
Health Authority: Croatia: Ministry of Health and Social Care

Keywords provided by General Hospital Dubrovnik:
sevoflurane
isoflurane
anaesthesia

Additional relevant MeSH terms:
Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Hematologic Agents
Physiological Effects of Drugs
Isoflurane
Central Nervous System Depressants
Anesthetics
Platelet Aggregation Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Sevoflurane

ClinicalTrials.gov processed this record on November 25, 2009