NCT03214653

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

July 10, 2017

Last Update Submit

February 27, 2018

Conditions

Renal Transplant Recipient Patients

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Sevoflurane

ACTIVE COMPARATOR

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

Drug: Sevoflurane

Interventions

PropofolDRUG

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

Propofol
SevofluraneDRUG

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

Sevoflurane

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects with body mass index \<21 or \>30 and Charlson Comorbidity Index \>4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (13)

  • 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.

    PMID: 17944639BACKGROUND

  • 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.

    PMID: 22778888BACKGROUND

  • 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.

    PMID: 26022013BACKGROUND

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

    PMID: 20640114BACKGROUND

  • 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.

    PMID: 22974856BACKGROUND

  • 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.

    PMID: 23614926BACKGROUND

  • 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.

    PMID: 17954155BACKGROUND

  • 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.

    PMID: 23110290BACKGROUND

  • 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.

    PMID: 12974148BACKGROUND

  • 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.

    PMID: 23010898BACKGROUND

  • 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.

    PMID: 27858374BACKGROUND

  • 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.

    PMID: 24390745BACKGROUND

  • 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.

    PMID: 26404434BACKGROUND

MeSH Terms

Interventions

PropofolSevoflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 11, 2017

Study Start

July 1, 2017

Primary Completion

November 30, 2017

Study Completion

January 31, 2018

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

ID(1)