Comparison Between Target-controlled Infusion of Propofol and Sevoflurane as Maintenance of Anesthesia to Hemodynamic Profile of Renal Transplant Recipient

Study Overview
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Brief Summary
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This study aimed to compare the effect of target-controlled infusion of propofol and sevoflurane as maintenance of anesthesia to intraoperative hemodynamic profile of renal transplant recipient

Detailed Description
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Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects were randomized into two groups which are target-controlled infusion (TCI) of propofol and sevoflurane. Electrocardiography, pulse oximetry, and non-invasive blood pressure were set on subjects in the operating room. Subjects were given intravenous ranitidine 50 mg, intravenous ondansetron 4 mg, intravenous methylprednisolone 500 mg, intravenous cefoperazone-sulbactam 2 gram, intravenous fentanyl 1 mkg/kg body weight (BW), and intravenous midazolam 1,5-2 mg as premedication. Arterial cannula was placed on radial artery to monitor arterial pressure. Epidural catheter was set and epidural test dosage was administered using epinephrine: lidocaine 2% = 1: 200.000 with 3ml volume. Central venous catheter was set using ultrasonography guidance with central venous cannula connected to EV1000TM monitor using monitoring kit to obtain hemodynamic profile before induction. Bispectral index probe was set on subjects. Induction was done using intravenous fentanyl 3 mkg/kg BW bolus 30 seconds and intravenous propofol 1-1,5 mg/kg BW bolus 60-90 seconds while endotracheal tube intubation was facilitated using intravenous atracurium 0.5 mg/kg BW. After subjects were intubated, sevoflurane 1,5-2% was used as maintenance agent for sevoflurane group while TCI of propofol was used using Schinder technique effect mode for propofol group. The administration of maintenance agent was adjusted by the depth of sedation using bispectral index monitor with target of 45-50. After completion of induction, hemodynamic profile was recorded once. Intravenous atracuriom 0,2 mg/kg BW was given repeatedly as muscle relaxant every 30 minutes after intubation. Fentanyl was given continuously as intraoperative analgesic with dosage 2mkg/kgBW/hour. If pulse rate was increased> 20% intraoperatively, an additional intravenous fentanyl 1 mkg/kgBW bolus was given. After first incision by operator, hemodynamic profile were recorded through screen capture of EV1000TM monitor, data will be saved in flash disc and manually on paper. Incision data will be recorded 3 times with 1 minute interval. Hemodynamic profile at incision is the average of all three recorded times. Further data will then be recorded every 15 minutes. After operator has finished preparing new kidney field, mannitol will be administered by drip slowly with dosage 0.5-1 gram/kg BW. After donor kidney placed on recipient field and renal vein connected, 40 mg intravenous furosemide was given. Hemodynamic profile was recorded 1 minute after clamp for renal artery has been opened and 15 minutes after. Vasoactive and inotropic drug were titrated if necessary to achieve mean arterial pressure before induction.

Official Title
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Comparison Between the Effect of Target-controlled Infusion of Propofol and Sevoflurane as Maintenance of Anesthesia to Intraoperative Hemodynamic Profile of Renal Transplant Recipient

Conditions
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Renal Transplant Recipient Patients

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 16-65 years old who is renal transplant recipient with body mass index of 21-30 kg/m2 and Charlson Comorbidity Index 1-4. Patients agreed to enroll and have signed the informed consent form. Exclusion Criteria: Subjects with body mass index <21 or >30 and Charlson Comorbidity Index >4

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Those who received target-controlled infusion of propofol using Schinder technique effect mode with the administration of maintenance agent was adjusted by the depth of sedation using bispectral index monitor with target of 45-50. | Drug: Propofol<br>* Subjects were given target-controlled infusion of propofol using Schinder technique effect mode with the administration of maintenance agent was adjusted by the depth of sedation using bispectral index monitor with target of 45-50<br>|
| Active Comparator: Sevoflurane<br>Those who received sevoflurane 1,5-2% as maintenance agent of anesthesia. | Drug: Sevoflurane<br>* Subjects were given sevoflurane 1,5-2% as maintenance agent of anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac index |  | 1 minute after incision | 
| Mean arterial pressure |  | 1 minute after incision | 
| Stroke volume index |  | 1 minute after incision | 
| Systemic vascular resistance index |  | 1 minute after incision |