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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
Sponsor:
Information provided by (Responsible Party):
Carlos Gustavo dos Santos Silva, Instituto Dante Pazzanese de Cardiologia

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane




Primary Outcome Measures :
  1. The effective dose of sevoflurane (ED 95) in cardiac surgery have no intraoperative awareness. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Neurocognitive assessment using the Mini Mental Test [ Time Frame: 6 months ]
  2. Recall intraoperative reported by the patient in post-operative period [ Time Frame: 6 months ]
  3. Time of endotracheal intubation [ Time Frame: 6 months ]
  4. Length of stay in intensive care unit (ICU) [ Time Frame: 6 months ]
  5. Length of stay in hospital stay. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with physical status ASA II to III undergoing first elective cardiac surgery for mitral and / or tricuspid valve with cardiopulmonary bypass undergoing general anesthesia;
Criteria

Inclusion Criteria:

  • Patients with physical status ASA II to III undergoing first elective cardiac surgery for mitral and / or tricuspid valve with cardiopulmonary bypass undergoing general anesthesia;

Exclusion Criteria:

  • Patients with contraindications to the study drugs; Reoperations cardiac surgery; History of psychiatric or neurological disease, drug abuse, or drugs known to affect the central nervous system; Pregnancy; Emergency procedures; Neuraxial blockade;

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): NCT02711384


Contacts
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Contact: Carlos Silva 55 11 98105 5252 cgss_phb@hotmail.com

Locations
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Brazil
Instituto Dante Pazzanese de Cardiologia Recruiting
Sao Paulo, SP, Brazil, 04012-909
Contact: Carlos Silva    55 11 98105 5252    cgss_phb@hotmail.com   
Sponsors and Collaborators
Instituto Dante Pazzanese de Cardiologia

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Responsible Party: Carlos Gustavo dos Santos Silva, MD, Instituto Dante Pazzanese de Cardiologia
ClinicalTrials.gov Identifier: NCT02711384     History of Changes
Other Study ID Numbers: 4555
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Mitral Valve Stenosis
Tricuspid Valve Insufficiency
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs