Determine the Effective Dose 95 of Sevoflurane in Adult Patients
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|ClinicalTrials.gov Identifier: NCT02711384|
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : August 14, 2019
Introduction: Sevoflurane is the most volatile anesthetic used during CPB. In addition to the cardioprotective effect, Sevoflurane also promotes reduction in systemic vascular resistance and also an important role in anesthesia maintenance during surgery, preventing patients awaken in the intraoperative. To avoid the awakening during surgery, assessment of the level of consciousness through the bispectral index (BIS) has been the most common method used by anesthesiologists. During cardiac surgery the most critical moment may be the patient is awaken during the warm up phase of CPB. The monitoring of this phase with the BIS has become efficient as to alert the anesthetist that the patient may be waking up.
Aims: The primary endpoint of this study is to determine the ideal minimum dose of sevoflurane (ED 95) that 95% of patients undergoing anesthesia during CPB in cardiac surgery have no intraoperative awareness.
Methodology: Dixon's up-and-down technique is a commonly used method to define MAC (27-30). The anesthetic concentration applied to the first patient is estimated by clinical experience. If there BIS values below 50, the concentration of inhalational anesthetic in subsequent patient is decreased by 20%. If the BIS show values greater than or equal to 50 for a period ≥ 1 minute steadily, the concentration is increased by 20% in the next patient. In each series of patients, the pairs of independent cross in order measurements are identified. Logistic regression is used to determine the ideal minimum dose of sevoflurane (ED 95) that 95% of patients undergoing anesthesia during CPB in cardiac surgery have no intraoperative awareness.
|Condition or disease|
|Mitral Stenosis Mitral Insufficiency Tricuspid Stenosis Tricuspid Insufficiency|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Determine the Effective Dose 95 of Sevoflurane in Adult Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass.|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
- The effective dose of sevoflurane (ED 95) in cardiac surgery have no intraoperative awareness. [ Time Frame: 6 months ]
- Neurocognitive assessment using the Mini Mental Test [ Time Frame: 6 months ]
- Recall intraoperative reported by the patient in post-operative period [ Time Frame: 6 months ]
- Time of endotracheal intubation [ Time Frame: 6 months ]
- Length of stay in intensive care unit (ICU) [ Time Frame: 6 months ]
- Length of stay in hospital stay. [ Time Frame: 6 months ]
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): NCT02711384
|Contact: Carlos Silva||55 11 98105 firstname.lastname@example.org|
|Instituto Dante Pazzanese de Cardiologia||Recruiting|
|Sao Paulo, SP, Brazil, 04012-909|
|Contact: Carlos Silva 55 11 98105 5252 email@example.com|