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

Primary Purpose

Hyperglycemia Stress

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TIVA
VIMA
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperglycemia Stress focused on measuring Anesthesia, intravenous, Anesthesia, inhalation, propofol, sevoflurane, glucose

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yeungnam University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Total intravenous anesthesia

volatileinduction maintenance anesthesia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Perioperative glucose level
The blood glucose level measured by the patient's blood sample

Secondary Outcome Measures

Perioperative insulin and cortisol levels
Insulin and cortisol concentrations measured in blood samples of patient

Full Information

First Posted
March 23, 2017
Last Updated
January 24, 2019
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03094533
Brief Title
TIVA and VIMA on Blood Glucose and Insulin Levels in Lung Lobectomy Patients
Official Title
The Effect of Total Intravenous Anesthesia and Volatile Induction and Maintenance Anesthesia on Perioperative Blood Glucose and Insulin Levels in Patients Undergoing Lung Lobectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia Stress
Keywords
Anesthesia, intravenous, Anesthesia, inhalation, propofol, sevoflurane, glucose

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total intravenous anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
volatileinduction maintenance anesthesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TIVA
Other Intervention Name(s)
propofol
Intervention Description
total intravenous anesthesia with propofol
Intervention Type
Drug
Intervention Name(s)
VIMA
Other Intervention Name(s)
sevoflurane
Intervention Description
volatile induction and maintenance anesthesia with sevoflurane
Primary Outcome Measure Information:
Title
Perioperative glucose level
Description
The blood glucose level measured by the patient's blood sample
Time Frame
up to 1 hour after surgery
Secondary Outcome Measure Information:
Title
Perioperative insulin and cortisol levels
Description
Insulin and cortisol concentrations measured in blood samples of patient
Time Frame
Baseline, 1 hour after incision, intraoperative, 1 hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Mee Jung, MD,PhD
Organizational Affiliation
Yeungnam University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
21602751
Citation
Cok OY, Ozkose Z, Pasaoglu H, Yardim S. Glucose response during craniotomy: propofol-remifentanil versus isoflurane-remifentanil. Minerva Anestesiol. 2011 Dec;77(12):1141-8. Epub 2011 May 20.
Results Reference
result
PubMed Identifier
19175019
Citation
Kitamura T, Kawamura G, Ogawa M, Yamada Y. [Comparison of the changes in blood glucose levels during anesthetic management using sevoflurane and propofol]. Masui. 2009 Jan;58(1):81-4. Japanese.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=OY+Cok%2C+Z+Ozkose%2C+H+Pasaoglu%2C+S+Yardim+%3A+Glucose+response+during+craniotomy%3A+propofol
Description
Isoflurane and propofol, both combined with remifentanil, provided clinically comparable cortisol and insulin responses to surgery in craniotomy operations, whereas propofol attenuated the increase in plasma blood glucose
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=Kitamura+T%2C+Kawamura+G%2C+Ogawa+M%2C+Yamada+Y+%3A+Comparison+of+the+changes+in+blood
Description
Results in this study imply that the effect on glucose metabolism of propofol is much less than that of sevoflurane

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

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