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

NCT03094533 | Completed DMC

• 1 other identifier: YUMC 2017-02-036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia Stress

Keywords

Anesthesia, intravenous; Anesthesia, inhalation; propofol; sevoflurane; glucose

Outcome Measures

Primary Outcomes (1)

• Perioperative glucose level

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

  up to 1 hour after surgery

Secondary Outcomes (1)

• Perioperative insulin and cortisol levels

  Baseline, 1 hour after incision, intraoperative, 1 hour after surgery

Study Arms (2)

Total intravenous anesthesia

ACTIVE COMPARATOR

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

volatileinduction maintenance anesthesia

ACTIVE COMPARATOR

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

Interventions

TIVA DRUG

total intravenous anesthesia with propofol

Also known as: propofol

Total intravenous anesthesia

VIMA DRUG

volatile induction and maintenance anesthesia with sevoflurane

Also known as: sevoflurane

volatileinduction maintenance anesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam University Hospital

Daegu, 42415, South Korea

Location

Related Publications (2)

• 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.

  PMID: 21602751 RESULT

• 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.

  PMID: 19175019 RESULT

Related Links

• 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
• Results in this study imply that the effect on glucose metabolism of propofol is much less than that of sevoflurane

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Sung Mee Jung, MD,PhD

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 29, 2017
• Study Start: April 3, 2017
• Primary Completion: October 31, 2018
• Study Completion: November 30, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)