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Assessment of clinical implication of bispectral index system in patient sedation

Effect of use of Bispecteral index monitoring on outcomes of undergoing mechanical ventilation hospitalized patients in intensive care units after open heart surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016061428467N1
Enrollment
110
Registered
2017-11-01
Start date
2017-03-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ventilated patient in icu after open heart surgery. ????????? ??????? ????

Interventions

Intervention 1: " Control group: post operation icu addmition
sedatin control according to the previous routine by nurse
Persedex PCA, midazolam, morphin, apotel, ketrolac administering according the protochol and nursing decision
consuming drug record
extubation time record
icu stay and hospital stay record.". Intervention 2: "intervention group: post operation icu addmission
connect ing bispectral index system to pateint from arrival time to extubation time and sedation score record per 2 hours
drug administerating according bis score and the protochol
icu stay and hospital stay record. ".
Treatment - Other
Treatment - Drugs
" Control group: post operation icu addmition
icu stay and hospital stay record."
"intervention group: post operation icu addmission

Sponsors

Vice chancellor for research Shahid Rajayi Heart Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:age range between 30 to 75 years, deduction equal 30 percent more a drain lip; the lack of a history of cerebrovascular accidents; lack of addiction to alcohol and drugs; fully under the emergency open heart surgery is not time equal less than 100 minutes aorta clamps; Cardiopulmonary bypass time less than equal to 120 minutes; during the action need to be inside the pump the aorta balloons placement; the duration of anesthesia equal less than 10 hours; total eclipses between 1-4 and without anderecthomy The exclusion criteria of the study:the patients after surgery following complications suffered are not: Myocardial infarction; cerebral and neurological complications; clotting problems; surgery; cardiac output reduction syndrome; a dangerous arrhythmias require resuscitation; pnemothorax; renal failer mechanical ventilation more than 12 hours after admission to the ICU, the trachea inside the tubing need to reset, the duration of the surgical time over 8 hours, need to re-surgery, bleeding more than 100 cc in the hours after the withdrawal of the patient from the operating room, the instability of hemodynamic status, cardiopulmonary resuscitation, the death of the patient

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Measure of sedative drug dosage. Timepoint: while intervention. Method of measurement: bispectral index system.

Secondary

MeasureTime frame
Ventilation duration. Timepoint: of patient enterance to icu until extubation. Method of measurement: observation and record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElnaz Boorghni Farahani

Shahid Rajayi Heart Center

elnaz.frhn@gmail.com+98 21 23921

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026