AnaesthesiaNCT00521612
Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery
A study testing sevoflurane and isoflurane in people with Anaesthesia, run by General Hospital Dubrovnik at 1 site in Croatia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaesthesia
- What is being tested?
- sevoflurane and isoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCroatia
- Study dates
- Sep 2007to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- Anaesthesia
- Being tested
- sevoflurane, isoflurane
- Keywords
- sevoflurane, isoflurane, anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneDrug
Also called Sevorane
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.
isofluraneDrug
Also called Forane
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Sevoflurane group, experimental group Receives: Drug: sevoflurane |
| B | Active comparator | Isoflurane group, control group Receives: Drug: isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between volatile anaesthetic sevoflurane and volatile anaesthetic isoflurane for providing low-flow general anaesthesia for abdominal surgery.
Measured: approximately time for this trial is about 2 months
Secondary outcomes (1)
Differences in awakening patients from low-flow general anaesthesia provided by sevoflurane and isoflurane.
Measured: approximately time for this trial is about 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Dubrovnik
- Sponsor type
- University, hospital or other
- Investigators
- Ante Crncevic, MD, MSc., Principal investigator, specialist in anaesthesiology and intensive care medicineZoran Dogas, MD, PhD., Study chair, Professor of Neuroscience, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521612
- Sponsor's protocol ID
- 75736
- Status last verified
- Dec 2007
- First submitted
- 27 Aug 2007
- Last updated
- 7 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1017/S0265021506001980. Epub 2007 Jan 4.
PubMed 17202009Venkatesh BG, Mehta Y, Kumar A, Trehan N. Comparison of sevoflurane and isoflurane in OPCAB surgery. Ann Card Anaesth. 2007 Jan;10(1):46-50. doi: 10.4103/0971-9784.37924.
PubMed 17455408Seitsonen 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. doi: 10.1016/j.jclinane.2005.12.005.
PubMed 16797429Sakai EM, Connolly LA, Klauck JA. Inhalation anesthesiology and volatile liquid anesthetics: focus on isoflurane, desflurane, and sevoflurane. Pharmacotherapy. 2005 Dec;25(12):1773-88. doi: 10.1592/phco.2005.25.12.1773.
PubMed 16305297Nakayama 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. doi: 10.1007/s00540-003-0186-4.
PubMed 14625708
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Controled Trial: Comparison of Volatile Anaesthetics Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00521612
- Acronym / sponsor ID
- 75736
- Conditions
- Anaesthesia
- Keywords
- sevoflurane, isoflurane, anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- General Hospital DubrovnikUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: sevofluraneSevoflurane group, experimental group |
| B | Active comparator | Drug: isofluraneIsoflurane group, control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients younger than 18 years
- Patients ASA III and higher
- Patients who need urgent abdominal surgery
- Patients allergic to anaesthetics
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sevofluraneAlso: SevoraneVolatile 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. | Drug | A |
| isofluraneAlso: ForaneVolatile 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. | Drug | B |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2008.
- Background: PubMed 17202009Mahajan 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. doi: 10.1017/S0265021506001980. Epub 2007 Jan 4.
- Background: PubMed 17455408Venkatesh BG, Mehta Y, Kumar A, Trehan N. Comparison of sevoflurane and isoflurane in OPCAB surgery. Ann Card Anaesth. 2007 Jan;10(1):46-50. doi: 10.4103/0971-9784.37924.
- Background: PubMed 16797429Seitsonen 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. doi: 10.1016/j.jclinane.2005.12.005.
- Background: PubMed 16305297Sakai EM, Connolly LA, Klauck JA. Inhalation anesthesiology and volatile liquid anesthetics: focus on isoflurane, desflurane, and sevoflurane. Pharmacotherapy. 2005 Dec;25(12):1773-88. doi: 10.1592/phco.2005.25.12.1773.
- Background: PubMed 14625708Nakayama 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. doi: 10.1007/s00540-003-0186-4.
- Web site of General Hospital DubrovnikLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ante Crncevic, MD, MSc. principal investigator
specialist in anaesthesiology and intensive care medicine
Zoran Dogas, MD, PhD. study chair
Professor of Neuroscience, University of Split, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sevoflurane and isoflurane in people with Anaesthesia, run by General Hospital Dubrovnik at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00521612, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2008.