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

February 27, 2018 updated by: Dita Aditianingsih, Indonesia University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: 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.
Drug: 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
ACTIVE_COMPARATOR: Sevoflurane
Those who received sevoflurane 1,5-2% as maintenance agent of anesthesia.
Drug: Sevoflurane
Subjects were given sevoflurane 1,5-2% as maintenance agent of anesthesia.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cardiac index
Time Frame: 1 minute after incision
1 minute after incision
Mean arterial pressure
Time Frame: 1 minute after incision
1 minute after incision
Stroke volume index
Time Frame: 1 minute after incision
1 minute after incision
Systemic vascular resistance index
Time Frame: 1 minute after incision
1 minute after incision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IndonesiaUAnes019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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