Two Different Preparations of Sevoflurane in Induction
A Randomized Clinical Trial on the Efficiency, Hemodynamic Effects and Patient Comfort of Two Different Preparations of Sevoflurane After Vital Capacity Rapid Inhalation Induction
1 other identifier
interventional
200
1 country
1
Brief Summary
In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity rapid inhalation induction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 19, 2013
April 1, 2013
2 months
February 12, 2013
April 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
1 hour
Secondary Outcomes (1)
effect of different sevoflurane preparations on hemodynamics
1 hour
Study Arms (2)
Sevoflurane A
ACTIVE COMPARATORGeneric sevoflurane
Sevoflurane B
ACTIVE COMPARATOROrginal sevoflurane
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing abdominal surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Istanbul, Fatih, 34400, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 17513639BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.Prof
Study Record Dates
First Submitted
February 12, 2013
First Posted
February 15, 2013
Study Start
February 1, 2013
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
April 19, 2013
Record last verified: 2013-04