Hyperglycemia StressNCT03094533
TIVA and VIMA on Blood Glucose and Insulin Levels in Lung Lobectomy Patients
A study testing TIVA and VIMA in people with Hyperglycemia Stress, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperglycemia Stress
- What is being tested?
- TIVA and VIMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Apr 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-diabetic patients American Society of Anesthesiologist Physical Status Classification 1 - 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Hyperglycemia Stress
- Being tested
- TIVA, VIMA
- Keywords
- Anesthesia, intravenous, Anesthesia, inhalation, propofol, sevoflurane, glucose
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVADrug
Also called propofol
total intravenous anesthesia with propofol
VIMADrug
Also called sevoflurane
volatile induction and maintenance anesthesia with sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: VIMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative glucose level
The blood glucose level measured by the patient's blood sample
Measured: up to 1 hour after surgery
Secondary outcomes (1)
Perioperative insulin and cortisol levels
Insulin and cortisol concentrations measured in blood samples of patient
Measured: Baseline, 1 hour after incision, intraoperative, 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start3 Apr 2017
- Primary completion31 Oct 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyperglycemia StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Mee Jung, Yeungnam University College of Medicine
- Investigators
- Sung Mee Jung, MD,PhD, Principal investigator, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094533
- Sponsor's protocol ID
- YUMC 2017-02-036
- Status last verified
- Jan 2019
- First submitted
- 23 Mar 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 21602751Kitamura 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.
PubMed 19175019
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03094533
- Acronym / sponsor ID
- YUMC 2017-02-036
- Conditions
- Hyperglycemia Stress
- Keywords
- Anesthesia, intravenous, Anesthesia, inhalation, propofol, sevoflurane, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia | Active comparator | Drug: TIVAIn 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. |
| volatileinduction maintenance anesthesia | Active comparator | Drug: VIMAIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-diabetic patients American Society of Anesthesiologist Physical Status Classification 1 - 3
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIVAAlso: propofoltotal intravenous anesthesia with propofol | Drug | Total intravenous anesthesia |
| VIMAAlso: sevofluranevolatile induction and maintenance anesthesia with sevoflurane | Drug | volatileinduction maintenance anesthesia |
Primary outcome
Perioperative glucose level
Time frame: up to 1 hour after surgery
The blood glucose level measured by the patient's blood sample
1 secondary outcome
Perioperative insulin and cortisol levels
Time frame: Baseline, 1 hour after incision, intraoperative, 1 hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Results publication: PubMed 21602751Cok 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 publication: PubMed 19175019Kitamura 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.
- 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 glucoseLink provided by the sponsor.
- Results in this study imply that the effect on glucose metabolism of propofol is much less than that of sevofluraneLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Mee Jung, MD,PhD principal investigator
Yeungnam University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIVA and VIMA in people with Hyperglycemia Stress, run by Yeungnam University College of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative glucose level (time frame: up to 1 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094533, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.