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

NCT ID: NCT03214653

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-01-31

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.

Conditions

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Renal Transplant Recipient Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Propofol

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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Sevoflurane

Those who received sevoflurane 1,5-2% as maintenance agent of anesthesia.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Subjects were given sevoflurane 1,5-2% as maintenance agent of anesthesia.

Interventions

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Propofol

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

Intervention Type DRUG

Sevoflurane

Subjects were given sevoflurane 1,5-2% as maintenance agent of anesthesia.

Intervention Type DRUG

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dita Aditianingsih

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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SarinKapoor H, Kaur R, Kaur H. Anaesthesia for renal transplant surgery. Acta Anaesthesiol Scand. 2007 Nov;51(10):1354-67. doi: 10.1111/j.1399-6576.2007.01447.x.

Reference Type BACKGROUND
PMID: 17944639 (View on PubMed)

Park JH, Lee JH, Joo DJ, Song KJ, Kim YS, Koo BN. Effect of sevoflurane on grafted kidney function in renal transplantation. Korean J Anesthesiol. 2012 Jun;62(6):529-35. doi: 10.4097/kjae.2012.62.6.529. Epub 2012 Jun 19.

Reference Type BACKGROUND
PMID: 22778888 (View on PubMed)

Amir-Zargar MA, Gholyaf M, Kashkouli AI, Moradi A, Torabian S. Comparison of safety and efficacy of general and spinal anesthesia in kidney transplantation: Evaluation of the peri-operative outcome. Saudi J Kidney Dis Transpl. 2015 May-Jun;26(3):447-52. doi: 10.4103/1319-2442.157300.

Reference Type BACKGROUND
PMID: 26022013 (View on PubMed)

Baxi V, Jain A, Dasgupta D. Anaesthesia for renal transplantation: an update. Indian J Anaesth. 2009 Apr;53(2):139-47.

Reference Type BACKGROUND
PMID: 20640114 (View on PubMed)

Grosso G, Corona D, Mistretta A, Zerbo D, Sinagra N, Giaquinta A, Tallarita T, Ekser B, Leonardi A, Gula R, Veroux P, Veroux M. Predictive value of the Charlson comorbidity index in kidney transplantation. Transplant Proc. 2012 Sep;44(7):1859-63. doi: 10.1016/j.transproceed.2012.06.042.

Reference Type BACKGROUND
PMID: 22974856 (View on PubMed)

Soga T, Kawahito S, Oi R, Kakuta N, Katayama T, Wakamatsu N, Takaishi K, Yamaguchi K, Izaki H, Kanayama HO, Kitahata H, Oshita S. Recent less-invasive circulatory monitoring during renal transplantation. J Med Invest. 2013;60(1-2):159-63. doi: 10.2152/jmi.60.159.

Reference Type BACKGROUND
PMID: 23614926 (View on PubMed)

Teixeira S, Costa G, Costa F, da Silva Viana J, Mota A. Sevoflurane versus isoflurane: does it matter in renal transplantation? Transplant Proc. 2007 Oct;39(8):2486-8. doi: 10.1016/j.transproceed.2007.07.038.

Reference Type BACKGROUND
PMID: 17954155 (View on PubMed)

Witkowska M, Karwacki Z, Rzaska M, Niewiadomski S, Sloniewski P. Comparison of target controlled infusion and total intravenous anaesthesia with propofol and remifentanil for lumbar microdiscectomy. Anaesthesiol Intensive Ther. 2012 Jul-Sep;44(3):138-44.

Reference Type BACKGROUND
PMID: 23110290 (View on PubMed)

Husedzinovic I, Tonkovic D, Barisin S, Bradic N, Gasparovic S. Hemodynamic differences in sevoflurane versus propofol anesthesia. Coll Antropol. 2003 Jun;27(1):205-12.

Reference Type BACKGROUND
PMID: 12974148 (View on PubMed)

Schmid S, Jungwirth B. Anaesthesia for renal transplant surgery: an update. Eur J Anaesthesiol. 2012 Dec;29(12):552-8. doi: 10.1097/EJA.0b013e32835925fc.

Reference Type BACKGROUND
PMID: 23010898 (View on PubMed)

Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.

Reference Type BACKGROUND
PMID: 27858374 (View on PubMed)

Huang YQ, Gou R, Diao YS, Yin QH, Fan WX, Liang YP, Chen Y, Wu M, Zang L, Li L, Zang J, Cheng L, Fu P, Liu F. Charlson comorbidity index helps predict the risk of mortality for patients with type 2 diabetic nephropathy. J Zhejiang Univ Sci B. 2014 Jan;15(1):58-66. doi: 10.1631/jzus.B1300109.

Reference Type BACKGROUND
PMID: 24390745 (View on PubMed)

Li F, Yuan Y. Meta-analysis of the cardioprotective effect of sevoflurane versus propofol during cardiac surgery. BMC Anesthesiol. 2015 Sep 24;15:128. doi: 10.1186/s12871-015-0107-8.

Reference Type BACKGROUND
PMID: 26404434 (View on PubMed)

Other Identifiers

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IndonesiaUAnes019

Identifier Type: -

Identifier Source: org_study_id