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Trial record 12 of 658 for:    Sevoflurane

Two Different Preparations of Sevoflurane in Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01792063
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Guniz M.Koksal, Istanbul University

Brief Summary:
In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity rapid inhalation induction.

Condition or disease Intervention/treatment Phase
Coughing on Induction Vapors; Inhalation Drug: Sevoflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : February 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arm Intervention/treatment
Active Comparator: Sevoflurane A
Generic sevoflurane
Drug: Sevoflurane
Other Name: Sevorane, Abbott Laboratories

Active Comparator: Sevoflurane B
Orginal sevoflurane
Drug: Sevoflurane
Other Name: Sojourn, Adeka IS A.S




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792063


Locations
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Turkey
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Istanbul, Fatih, Turkey, 34400
Sponsors and Collaborators
Istanbul University

Publications:
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Responsible Party: Guniz M.Koksal, Assoc.Prof, Istanbul University
ClinicalTrials.gov Identifier: NCT01792063     History of Changes
Other Study ID Numbers: 43430
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
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Sevoflurane
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs