Back to resultsTwo Different Preparations of Sevoflurane in Induction
Primary Purpose
Coughing on Induction, Vapors; Inhalation
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Sevoflurane
Sevoflurane
Sponsored by
About this trial
This is an interventional prevention trial for Coughing on Induction
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing abdominal surgery
Exclusion Criteria:
- Patients with any cardiovascular or respiratory disease, usage of any kind of sedative drug, expected airway difficulty and obese patients (BMI>35) will be excluded from the study
Sites / Locations
- Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sevoflurane A
Sevoflurane B
Arm Description
Generic sevoflurane
Orginal sevoflurane
Outcomes
Primary Outcome Measures
effect of different preparations of sevoflurane on Induction on hypnosis time
Induction for anesthesia will be achieved with sevoflurane A and Sevoflurane B in total of 100 randomized (American Society of Anesthesiology status I-II) patients undergoing abdominal surgery. During the induction patients will be asked to breath as deep as possible and then hold their breaths to the point where they cannot anymore and flexing their right arm. Occurrence of hypnosis will be confirmed with both the loss of eyelash-reflex and failing of flexed-holding arm. Time and number of breaths needed for the loss of consciousness will be noted. Existence of hiccup, cough, increase in secretions, and refusal of the mask by the patient will be reported if any. All patients will be extubated and released to the ward after they are questioned about any discomfort or issue they want to report to anesthesiologist
Secondary Outcome Measures
effect of different sevoflurane preparations on hemodynamics
After the induction and occurrence of hypnosis, Systemic arterial pressure (SAP) values will be noted. Tracheal intubation will be performed and post-intubation SAP values will be noted. The SAP values will noted in the 5th minute of the induction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01792063
Brief Title
Two Different Preparations of Sevoflurane in Induction
Official Title
A Randomized Clinical Trial on the Efficiency, Hemodynamic Effects and Patient Comfort of Two Different Preparations of Sevoflurane After Vital Capacity Rapid Inhalation Induction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity rapid inhalation induction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coughing on Induction, Vapors; Inhalation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane A
Arm Type
Active Comparator
Arm Description
Generic sevoflurane
Arm Title
Sevoflurane B
Arm Type
Active Comparator
Arm Description
Orginal sevoflurane
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevorane, Abbott Laboratories
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sojourn, Adeka IS A.S
Primary Outcome Measure Information:
Title
effect of different preparations of sevoflurane on Induction on hypnosis time
Description
Induction for anesthesia will be achieved with sevoflurane A and Sevoflurane B in total of 100 randomized (American Society of Anesthesiology status I-II) patients undergoing abdominal surgery. During the induction patients will be asked to breath as deep as possible and then hold their breaths to the point where they cannot anymore and flexing their right arm. Occurrence of hypnosis will be confirmed with both the loss of eyelash-reflex and failing of flexed-holding arm. Time and number of breaths needed for the loss of consciousness will be noted. Existence of hiccup, cough, increase in secretions, and refusal of the mask by the patient will be reported if any. All patients will be extubated and released to the ward after they are questioned about any discomfort or issue they want to report to anesthesiologist
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
effect of different sevoflurane preparations on hemodynamics
Description
After the induction and occurrence of hypnosis, Systemic arterial pressure (SAP) values will be noted. Tracheal intubation will be performed and post-intubation SAP values will be noted. The SAP values will noted in the 5th minute of the induction.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing abdominal surgery
Exclusion Criteria:
Patients with any cardiovascular or respiratory disease, usage of any kind of sedative drug, expected airway difficulty and obese patients (BMI>35) will be excluded from the study
Facility Information:
Facility Name
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34400
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
17513639
Citation
Baker MT. Sevoflurane: are there differences in products? Anesth Analg. 2007 Jun;104(6):1447-51, table of contents. doi: 10.1213/01.ane.0000263031.96011.36.
Results Reference
background
Learn more about this trial
Two Different Preparations of Sevoflurane in Induction
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