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Trial record 14 of 101 for:    Recruiting, Not yet recruiting, Available Studies | "Blood Glucose"

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

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ClinicalTrials.gov Identifier: NCT03094533
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Sung Mee Jung, Yeungnam University College of Medicine

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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Stress Drug: TIVA Drug: VIMA Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: sevoflurane




Primary Outcome Measures :
  1. Perioperative glucose level [ Time Frame: up to 1 hour after surgery ]
    The blood glucose level measured by the patient's blood sample


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094533


Contacts
Contact: Sung Mee Jung, MD,PhD +82-53-620-3368 applejsm@gmail.com
Contact: Yong Bae Lee, MD +82-53-620-3368 toyland01@naver.com

Locations
Korea, Republic of
Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of, 42415
Contact: Sung Mee Jung, MD, PhD    +82-53-620--3368    applejsm@gmail.com   
Principal Investigator: Sung Mee Jung, M.D.         
Sponsors and Collaborators
Yeungnam University College of Medicine
Investigators
Principal Investigator: Sung Mee Jung, MD,PhD Yeungnam University Hospital

Additional Information:
Publications of Results:
Responsible Party: Sung Mee Jung, Professor, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT03094533     History of Changes
Other Study ID Numbers: YUMC 2017-02-036
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sung Mee Jung, Yeungnam University College of Medicine:
Anesthesia, intravenous
Anesthesia, inhalation
propofol
sevoflurane
glucose

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation