Renal Transplant Recipient PatientsNCT03214653
Comparison Between Target-controlled Infusion of Propofol and Sevoflurane as Maintenance of Anesthesia to Hemodynamic Profile of Renal Transplant Recipient
A study testing Propofol and Sevoflurane in people with Renal Transplant Recipient Patients, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Renal Transplant Recipient Patients
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2017to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects with body mass index <21 or >30 and Charlson Comorbidity Index >4
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Comparison Between the Effect of Target-controlled Infusion of Propofol and Sevoflurane as Maintenance of Anesthesia to Intraoperative Hemodynamic Profile of Renal Transplant Recipient
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
Read the detailed description
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
- Renal Transplant Recipient Patients
- Being tested
- Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
SevofluraneDrug
Subjects were given sevoflurane 1,5-2% as maintenance agent of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Propofol |
| Sevoflurane | Active comparator | Those who received sevoflurane 1,5-2% as maintenance agent of anesthesia. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac index
Measured: 1 minute after incision
Mean arterial pressure
Measured: 1 minute after incision
Stroke volume index
Measured: 1 minute after incision
Systemic vascular resistance index
Measured: 1 minute after incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Jul 2017
- Primary completion30 Nov 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant Recipient PatientsStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dita Aditianingsih, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214653
- Sponsor's protocol ID
- IndonesiaUAnes019
- Status last verified
- Feb 2018
- First submitted
- 10 Jul 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17944639Park 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.
PubMed 22778888Amir-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.
PubMed 26022013Baxi V, Jain A, Dasgupta D. Anaesthesia for renal transplantation: an update. Indian J Anaesth. 2009 Apr;53(2):139-47.
PubMed 20640114Grosso 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.
PubMed 22974856Soga 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.
PubMed 23614926Teixeira 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.
PubMed 17954155Witkowska 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.
PubMed 23110290Husedzinovic I, Tonkovic D, Barisin S, Bradic N, Gasparovic S. Hemodynamic differences in sevoflurane versus propofol anesthesia. Coll Antropol. 2003 Jun;27(1):205-12.
PubMed 12974148Schmid S, Jungwirth B. Anaesthesia for renal transplant surgery: an update. Eur J Anaesthesiol. 2012 Dec;29(12):552-8. doi: 10.1097/EJA.0b013e32835925fc.
PubMed 23010898Monnet 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.
PubMed 27858374Huang 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.
PubMed 24390745Li 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.
PubMed 26404434
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Target-controlled Infusion of Propofol and Sevoflurane as Maintenance of Anesthesia to Intraoperative Hemodynamic Profile of Renal Transplant Recipient
- ClinicalTrials.gov ID
- NCT03214653
- Acronym / sponsor ID
- IndonesiaUAnes019
- Conditions
- Renal Transplant Recipient Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolThose 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. |
| Sevoflurane | Active comparator | Drug: SevofluraneThose who received sevoflurane 1,5-2% as maintenance agent of anesthesia. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects with body mass index <21 or >30 and Charlson Comorbidity Index >4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolSubjects 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 | Drug | Propofol |
| SevofluraneSubjects were given sevoflurane 1,5-2% as maintenance agent of anesthesia. | Drug | Sevoflurane |
Primary outcome
Cardiac index
Time frame: 1 minute after incision
Mean arterial pressure
Time frame: 1 minute after incision
Stroke volume index
Time frame: 1 minute after incision
Systemic vascular resistance index
Time frame: 1 minute after incision
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 17944639SarinKapoor 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.
- Background: PubMed 22778888Park 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.
- Background: PubMed 26022013Amir-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.
- Background: PubMed 20640114Baxi V, Jain A, Dasgupta D. Anaesthesia for renal transplantation: an update. Indian J Anaesth. 2009 Apr;53(2):139-47.
- Background: PubMed 22974856Grosso 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.
- Background: PubMed 23614926Soga 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.
- Background: PubMed 17954155Teixeira 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.
- Background: PubMed 23110290Witkowska 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.
- Background: PubMed 12974148Husedzinovic I, Tonkovic D, Barisin S, Bradic N, Gasparovic S. Hemodynamic differences in sevoflurane versus propofol anesthesia. Coll Antropol. 2003 Jun;27(1):205-12.
- Background: PubMed 23010898Schmid S, Jungwirth B. Anaesthesia for renal transplant surgery: an update. Eur J Anaesthesiol. 2012 Dec;29(12):552-8. doi: 10.1097/EJA.0b013e32835925fc.
- Background: PubMed 27858374Monnet 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.
- Background: PubMed 24390745Huang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Renal Transplant Recipient Patients, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac index (time frame: 1 minute after incision). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03214653, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.