TIVA and VIMA on Blood Glucose and Insulin Levels in Lung Lobectomy Patients

January 24, 2019 updated by: Sung Mee Jung, Yeungnam University College of Medicine

The Effect of Total Intravenous Anesthesia and Volatile Induction and Maintenance Anesthesia on Perioperative Blood Glucose and Insulin Levels in Patients Undergoing Lung Lobectomy

The purpose of this study was to evaluate the efficacy and safety of sevoflurane-only Volatile induction and maintenance anesthesia (VIMA) and total intravenous anesthesia (TIVA) using only propofol in adult patients scheduled for elective lobectomy surgery. We would like to know if there is a difference in blood glucose levels during surgery and whether the cause is due to the difference in secretion of insulin and cortisol. In addition, we aim to contribute to the improvement of the prognosis of the patients by helping the selection of general anesthesia more effective in maintaining homeostasis in the surgical patients by general anesthesia and further controlling the blood glucose level.

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

Before surgery, glycopyrrolate (0.2 mg) was administered intramuscularly. Immediately after arrival in the operating room, blood pressure, electrocardiogram and oxygen saturation are measured and monitored, and a bispectral index (BIS) is attached to the patient's forehead to determine the appropriate anesthetic depth during surgery. A 22G angiocatheter is inserted into the radial artery after local anesthesia with lidocaine to monitor the blood pressure in real time and to collect blood for arterial blood gas analysis during one side of pulmonary ventilation. General anesthesia induces loss of consciousness by using a randomly assigned systemic anesthetic (sevoflurane inhalation or propofol infusion). In the VIMA group, when 8% sevoflurane is inhaled with 100% oxygen at 6 L / min and the consciousness is lost, the concentration of sevoflurane is reduced to 2-3% and then the mask is ventilated. In the TIVA group, target controlled infusion (TCI) was performed with propofol 4 mcg / ml, and the patient was ventilated after disappearance of consciousness. When the consciousness of the subject is lost, remifentanil is administered as TCI with a target concentration of 1 ng / ml as an analgesic agent, and rocuronium 0.5 mg / kg is administered intravenously for intubation in both groups. If the patient's anesthesia depth is between BIS 40-60 and the respiratory muscles are fully relaxed, tracheal intubation is performed using the double lumen endobronchial tube (DLT). After confirming the DLT reaches the proper position with a flexible bronchoscope, mechanical ventilation is started by administering 50% oxygen. The central venous catheter is inserted into the operative subclavian vein and the central venous pressure is continuously monitored during the operation. During surgery, rocuronium is administered continuously so that the train-of-four (TOF) remains below two responses. In addition, warm blanket and warm air are supplied to the rest of the body except for the surgical site so that the patient can maintain normothermia during the operation. In all patients, surgery should start between 8:30 am and 9:00 am in order to prevent volatility of blood cortisol levels by activity cycle. During surgery, general anesthesia should be adjusted to maintain BIS 40-60, and remifentanil TCI should be maintained at 1 ng / ml for pain during surgery. The mean blood pressure during surgery is aimed at maintaining a 30% range on baseline so that hypotension or hypertension does not last more than 5 minutes. Hypotension and hypertension are controlled by intravenous injection of phenylephrine (50 μg / ml) and nicardipine (500 μg / ml), respectively. At the end of the operation and after the paravertebral block to control the postoperative pain, the administration of the general anesthetic and remifentanil is stopped and the spontaneous breathing is tried to be recovered. When patients begin spontaneous breathing, the effect of the remaining neuromuscular blockers is reversed using pyridostigmine (0.2 mg / kg) and glycopyrrolate (0.008 mg / kg). All patients are fully conscious and have a spontaneous respiration when they are exhaled and transferred to the postanesthetic care unit (PACU). PACU administers oxygen through a facial mask and monitors blood pressure, heart rate and oxygen saturation. Patients should be given 1 ug / kg of fentanyl when the visual analog scale (VAS) scores exceed 4 points

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.
60

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

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-diabetic patients American Society of Anesthesiologist Physical Status Classification 1 - 3

Exclusion Criteria:

  • Diabetes mellitus or glucose intolerance patients, patients with adrenocortical hormone metabolism abnormality, patients with steroids therapy within the last month, patients with liver disease (aspartate aminotransferase> 40 IU / L or alanine aminotransferase> 40 IU / L), patients with kidney disease (creatinine 1.5 mg / dl), pregnant woman, patients with hypersensitivity to anesthetics used in research, patients who required ventilator care after surgery

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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: Total intravenous anesthesia
In the total intravenous anesthesia(TIVA) group, target controlled infusion (TCI) I was performed with propofol 4 mcg / ml. When the consciousness of the patient is lost, Remifentanil is administered as TCI with a target concentration of 1 ng / ml as an analgesic agent, and rocuronium 0.5 mg / kg is administered intravenously for intubation.
Drug: TIVA
total intravenous anesthesia with propofol
Other Names:
  • propofol
Active Comparator: volatileinduction maintenance anesthesia
In the volatile induction and maintenance anesthesia(VIMA) group, when 8% sevoflurane is inhaled with 100% oxygen at 6 L / min and the consciousness is lost, the concentration of sevoflurane is reduced to 2-3% and then the mask is ventilated.Remifentanil is administered as TCI with a target concentration of 1 ng / ml as an analgesic agent, and rocuronium 0.5 mg / kg is administered intravenously for intubation.
Drug: VIMA
volatile induction and maintenance anesthesia with sevoflurane
Other Names:
  • sevoflurane

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
Measure Description
Time Frame
Perioperative glucose level
Time Frame: up to 1 hour after surgery
The blood glucose level measured by the patient's blood sample
up to 1 hour after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perioperative insulin and cortisol levels
Time Frame: Baseline, 1 hour after incision, intraoperative, 1 hour after surgery
Insulin and cortisol concentrations measured in blood samples of patient
Baseline, 1 hour after incision, intraoperative, 1 hour after surgery

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.
Yeungnam University College of Medicine

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.
April 3, 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.
October 31, 2018

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.
November 30, 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).
March 23, 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.
March 28, 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.
March 29, 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.
January 25, 2019

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.
January 24, 2019

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.
January 1, 2019

More Information

Terms related to this study

Keywords

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.
  • YUMC 2017-02-036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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