COMPARISON OF THE EFFECTIVENESS OF THE TARGET-CONTROLLED INFUSION (TCI) ELEVEL AND SCHNIDER METHODS IN ACHIEVING ANESTHESIA DEPTH
Tahapan Penelitian : Recruit
Sponsor:
The individual
Mitra Pelaksana:
Not Specified
No Registry
INA-8OWCZ0OQ
Tanggal Input Registry : 17-03-2025
Tracking Information | |
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Tanggal Antisipasi Studi | 04-03-2025 |
Outcome Primer | Effect concentration (CE) of Propofol to achieve optimal depth of anesthesia for surgery with BIS value 50 on TCI Eleveld method compared with Schnider |
Outcome Skunder | average amount of propofol use |
Descriptive Information | |
Judul Penelitian Popular | COMPARISON OF THE EFFECTIVENESS OF THE TARGET-CONTROLLED INFUSION (TCI) ELEVEL AND SCHNIDER METHODS IN ACHIEVING ANESTHESIA DEPTH |
Judul Penelitian Ilmiah | COMPARISON OF THE EFFECTIVENESS OF THE TARGET-CONTROLLED INFUSION (TCI) ELEVEL AND SCHNIDER METHODS IN ACHIEVING ANESTHESIA DEPTH |
Jenis Penelitian | Interventional |
Intervensi | Pasien yang masuk kelompok TCI Propofol Model Eleveld 1. Saat di ruang operasi pasien dipasangkan elektroda EKG, manset untuk pemantauan tekanan darah, serta Pulse Oximetry untuk pemantauan saturasi oksigen perifer 2. Pasien dalam posisi supine, dahi pasien dibersihkan dari minyak dan kotoran menggunakan sabun kemudian dikeringkan. 3. Elektroda BIS Quatro dipasang pada salah satu sisi dahi pasien, kemudian dihubungkan dengan mesin BIS dan dilakukan kalibrasi sensor untuk mendapat nilai basal BIS pasien. 4. Mesin TCI Propofol Eleveld diatur sesuai parameter usia, jenis kelamin, tinggi badan, berat badan, dan penggunaan opioid. 5. Propofol dengan konsentrasi 10 mg/mL dimasukkan ke dalam sepuit 50 mL yang dipasang di mesin TCI kemudian disambungkan ke pasien menggunakan extension tube 150 cm. 6. Pasien dilakukan induksi dengan TCI propofol target efek (CE) awal 1 mcg/mL sambil dilihat nilai BIS yang tercapai. 7. Target efek (CE) TCI propofol di titrasi naik bertahap 0.5 mcg/mL setelah target efek sebelumnya tercapai hingga kedalaman anestesi optimal yang dilihat dari nilai BIS 50. 8. Setelah didapati nilai BIS 50 maka dilakukan pencatatan nilai target efek (CE) yang tercapai, tekanan darah, MAP. 9. Pasien kemudian diberikan analgesik dengan fentanyl 2 mcg/KgBB serta atracurium 0.5 mg/KgBB untuk fasilitasi intubasi 10. Setelah intubasi, dilakukan titrasi target efek (CE) propofol untuk menjaga nilai BIS 50 dan dilakukan pencatatan target efek (CE) yang tercapai, tekanan darah, MAP. 11. Pasien diberikan pemeliharaan dengan target efek (CE) propofol di titrasi naik atau turun 0.5 mcg/mL untuk menjaga nilai BIS mendekati 50. 12. Pemeliharaan analgesik dengan fentanyl 0.5-1 mcg/kgBB. Patients included in the TCI Propofol Model Eleveld group 1. When in the operating room, the patient is fitted with ECG electrodes, a cuff for blood pressure monitoring, and Pulse Oximetry for peripheral oxygen saturation monitoring 2. The patient is in a supine position, the patient's forehead is cleaned of oil and dirt using soap and then dried. 3. The BIS Quatro electrode is installed on one side of the patient's forehead, then connected to the BIS machine and the sensor is calibrated to obtain the patient's basal BIS value. 4. The TCI Propofol Eleveld machine is set according to the parameters of age, gender, height, weight, and opioid use. 5. Propofol with a concentration of 10 mg/mL is inserted into a 50 mL syringe installed in the TCI machine and then connected to the patient using a 150 cm extension tube. 6. The patient is induced with TCI propofol target effect (CE) of 1 mcg/mL while observing the BIS value achieved. 7. The target effect (CE) of TCI propofol is titrated up gradually by 0.5 mcg/mL after the previous target effect is achieved until the optimal anesthesia depth is seen from the BIS value of 50. 8. After the BIS value of 50 is obtained, the target effect (CE) value that is achieved, blood pressure, MAP is recorded. 9. The patient is then given analgesics with fentanyl 2 mcg/KgBW and atracurium 0.5 mg/KgBW to facilitate intubation 10. After intubation, titration of the target effect (CE) of propofol is carried out to maintain the BIS value of 50 and the target effect (CE) that is achieved, blood pressure, MAP is recorded. 11. The patient is given maintenance with the target effect (CE) of propofol titrated up or down by 0.5 mcg/mL to maintain the BIS value close to 50. 12. Maintenance of analgesics with fentanyl 0.5-1 mcg/kgBW. 13. Maintenance of atracurium 0.1 mg/kgBW is given as a bolus to maintain relaxation. 14. Patients who experience hypotension from the beginning of induction until the end of the TCI machine is stopped with systolic blood pressure below 90 mmHg are given fluid loading and ephedrine 5-10 mg if necessary until systolic blood pressure is above 90 mmHg according to the hypotension management procedure and the occurrence of hypotension is recorded. 15. Patients who experience repeated hypotension require continuous administration of vasoconstrictor drugs and are recorded as drop outs. 16. Patients who require the addition of other sedation drugs to achieve a BIS value of 50 from the beginning of induction until the end of anesthesia are recorded as drop outs. 17. At the end of the operation, the operation time and total propofol usage during the operation are recorded. |
Jumlah Subyek Penelitian | 44 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: 1. Patients aged 18 – 64 years 2. Patients with ASA physical status I – II 3. Patients undergoing surgery under general anesthesiaExclusion Criteria: 1. Patients with uncontrolled systemic diseases (hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma) 2. Patients with severe neurological disorders 3. Patients who are allergic to propofol 4. Patients who consume psychiatric drugs including benzodiazepines 5. Patients with a history of alcohol consumption |
Administrative Information | |
Nomor Persetujuan Etik | 0632/UN14.2.2.VII.14/LT/2025 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
Other Study ID Numbers | |
Contact Person | dr. damatus try hartanto taopan; no HP 081295808960; kode pos : 80114; metuzainferno@gmail.com |