Two Different Preparations of Sevoflurane in Induction

Vapors; Inhalation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792063
• Other study ID #: 43430
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2013
• Last updated: April 18, 2013
• Start date: February 2013
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coughing on Induction
• Respiratory Aspiration
• Vapors; Inhalation

Intervention

Drug:
• Sevoflurane

• Sevoflurane

Locations

Country	Name	City	State
Turkey	Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Baker MT. Sevoflurane: are there differences in products? Anesth Analg. 2007 Jun;104(6):1447-51, table of contents. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	1 hour	No