- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01792063
Two Different Preparations of Sevoflurane in Induction
April 18, 2013 updated by: Guniz M.Koksal, Istanbul University
A Randomized Clinical Trial on the Efficiency, Hemodynamic Effects and Patient Comfort of Two Different Preparations of Sevoflurane After Vital Capacity Rapid Inhalation Induction
In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity rapid inhalation induction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fatih
-
Istanbul, Fatih, Turkey, 34400
- Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sevoflurane A
Generic sevoflurane
|
Other Names:
|
Active Comparator: Sevoflurane B
Orginal sevoflurane
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effect of different preparations of sevoflurane on Induction on hypnosis time
Time Frame: 1 hour
|
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
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effect of different sevoflurane preparations on hemodynamics
Time Frame: 1 hour
|
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.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
February 12, 2013
First Submitted That Met QC Criteria
February 14, 2013
First Posted (Estimate)
February 15, 2013
Study Record Updates
Last Update Posted (Estimate)
April 19, 2013
Last Update Submitted That Met QC Criteria
April 18, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43430
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coughing on Induction
-
Ain Shams UniversityUnknown
-
Min SuRecruiting
-
University of ToledoRecruitingHypotension on InductionUnited States
-
Mount Sinai Hospital, CanadaCompleted
-
Mount Sinai Hospital, CanadaNot yet recruitingHypotension on InductionCanada
-
Cairo UniversityRecruitingHypotension on InductionEgypt
-
University Medical Center Ho Chi Minh City (UMC)RecruitingHypotension on InductionVietnam
-
Kangbuk Samsung HospitalNot yet recruitingHypotension on Induction
-
Taipei Medical UniversityNational Science Council, TaiwanActive, not recruitingHypotension on InductionTaiwan
-
Cairo UniversityCompletedHypotension on InductionEgypt
Clinical Trials on Sevoflurane
-
Yeungnam University College of MedicineCompleted
-
University of RostockCompletedOther Specified Injuries of Vocal Cord, SequelaGermany
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceTerminated
-
Kocaeli Derince Education and Research HospitalCompleted
-
Pontificia Universidad Catolica de ChileUnknown
-
Universiti Sains MalaysiaCompletedGeneral Anaesthesia | PaediatricsMalaysia
-
University Hospital, Clermont-FerrandCompleted
-
University Hospital, GhentCompleted
-
China International Neuroscience InstitutionCompletedGeneral Anesthesia | Urinary SurgeryChina