A Randomized Clinical Trial on the Efficiency, Hemodynamic Effects and Patient Comfort of Two Different Preparations of Sevoflurane After Vital Capacity Rapid Inhalation Induction

Istanbul University1 site in 1 country200 target enrollmentFebruary 2013

ConditionsCoughing on Induction Vapors; Inhalation

InterventionsSevoflurane

DrugsSevoflurane

Overview

Phase: Phase 4
Intervention: Sevoflurane
Conditions: Coughing on Induction
Sponsor: Istanbul University
Enrollment: 200
Locations: 1
Primary Endpoint: effect of different preparations of sevoflurane on Induction on hypnosis time
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

April 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Istanbul University

Responsible Party

Principal Investigator

Guniz M.Koksal

Assoc.Prof

Istanbul University

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

Arms & Interventions

Sevoflurane A

Generic sevoflurane

Intervention: Sevoflurane

Sevoflurane B

Orginal sevoflurane

Intervention: Sevoflurane

Outcomes

Primary Outcomes

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