Perioperative Blood Glucose and InsulinPhase 4NCT02154074
Dexmedetomidine Influence on the Level of Perioperative Blood Glucose and Insulin of Elderly Diabetes Patients
A Phase 4 study testing general anesthesia induction, Isoflurane and Dexmedetomidine in people with Perioperative Blood Glucose and Insulin, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
Dexmedetomidine is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, alleviate pain,and improve cardiovascular stability in the operation period. Dexmedetomidine have influence on perioperative stress response and immune function,but it is not clear. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Perioperative Blood Glucose and Insulin
- What is being tested?
- general anesthesia induction, Isoflurane and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Oct 2014
- Phase
- Phase 4
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 to 80 years old;
- Type 2 diabetes;
- Not use insulin treatment;
- Onging general anesthesia surgery;
- Surgery time 1-3 hours
Who cannot join
- ASA classification > class II;
- Hypertension;
- Serious central nervous system diseases (acute stroke, uncontrolled seizures, -Severe dementia);
- Unstable angina and acute myocardial infarction;
- Allergy to investigational drug;
- Hepatic and renal dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SecondXianJiaotongU
Xi’an, Shanxi
Hongtao Liu, 13572225310, lannylouis@163.com
About this study
Dexmedetomidine is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, alleviate pain,and improve cardiovascular stability in the operation period. Dexmedetomidine have influence on perioperative stress response and immune function,but it is not clear.
- Conditions
- Perioperative Blood Glucose and Insulin
- Being tested
- general anesthesia induction, Isoflurane, Dexmedetomidine, normal saline
- Keywords
- Dexmedetomidine perioperative blood glucose and insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesia inductionDrug
general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg
IsofluraneDrug
inhale Isoflurane 1.5MAC
DexmedetomidineDrug
anesthesia induction period: intravenous pumping Dexmedetomidine 4ug/Kg/h; after 10 minutes,turn to 0.4ug/Kg/h.
normal salineDrug
the same volume of saline + Isoflurane during operation
| Study group | Role | What they receive |
|---|---|---|
| N1 group: Isoflurane & saline | Active comparator | for normal patients: inhale Isoflurane + the same volume of saline during operation Receives: Drug: general anesthesia induction; Drug: Isoflurane; Drug: normal saline |
| N2 group: Isoflurane & Dexmedetomidine | Experimental | for normal patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation Receives: Drug: general anesthesia induction; Drug: Isoflurane; Drug: Dexmedetomidine |
| D1 group: Isoflurane & saline | Active comparator | for diabetes patients: inhale Isoflurane + the same volume of saline during operation Receives: Drug: general anesthesia induction; Drug: Isoflurane; Drug: normal saline |
| D2 group: Isoflurane & Dexmedetomidi | Experimental | for diabetes patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation Receives: Drug: general anesthesia induction; Drug: Isoflurane; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
measure blood glucose at 3 time points,the day before surgery,Intraoperative(1 hour after surgery begain),one day after surgery(24 hours after surgery); examine the concentration of blood glucose in serum.
Measured: from the day before surgery to 24 hours after surgery
level of blood insulin
measure the level of blood insulin at 3 time points,the day before surgery,Intraoperative(1 hour after surgery begain),one day after surgery(24 hours after surgery); use ELISA to examine the concentration of blood insulin in serum.
Measured: from the day before surgery to 24 hours after surgery
Secondary outcomes (1)
vital signs
measure the blood pressure(BP),heart rate(HR) and oxygen saturation(SpO2) in the perioperative period
Measured: duration of perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Blood Glucose and InsulinStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154074
- Sponsor's protocol ID
- Dexmedetomidine 20140527
- Status last verified
- May 2014
- First submitted
- 28 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Influence on the Level of Perioperative Blood Glucose and Insulin of Elderly Diabetes Patients
- ClinicalTrials.gov ID
- NCT02154074
- Acronym / sponsor ID
- Dexmedetomidine 20140527
- Conditions
- Perioperative Blood Glucose and Insulin
- Keywords
- Dexmedetomidine perioperative blood glucose and insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- 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.
Dexmedetomidine is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, alleviate pain,and improve cardiovascular stability in the operation period. Dexmedetomidine have influence on perioperative stress response and immune function,but it is not clear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| N1 group: Isoflurane & saline | Active comparator | Drug: general anesthesia induction, Drug: Isoflurane, Drug: normal salinefor normal patients: inhale Isoflurane + the same volume of saline during operation |
| N2 group: Isoflurane & Dexmedetomidine | Experimental | Drug: general anesthesia induction, Drug: Isoflurane, Drug: Dexmedetomidinefor normal patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation |
| D1 group: Isoflurane & saline | Active comparator | Drug: general anesthesia induction, Drug: Isoflurane, Drug: normal salinefor diabetes patients: inhale Isoflurane + the same volume of saline during operation |
| D2 group: Isoflurane & Dexmedetomidi | Experimental | Drug: general anesthesia induction, Drug: Isoflurane, Drug: Dexmedetomidinefor diabetes patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 60 to 80 years old;
- Type 2 diabetes;
- Not use insulin treatment;
- Onging general anesthesia surgery;
- Surgery time 1-3 hours
Key exclusion criteria (6 listed)
- ASA classification > class II;
- Hypertension;
- Serious central nervous system diseases (acute stroke, uncontrolled seizures, -Severe dementia);
- Unstable angina and acute myocardial infarction;
- Allergy to investigational drug;
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 |
|---|---|---|
| general anesthesia inductiongeneral anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg | Drug | D1 group: Isoflurane & saline, D2 group: Isoflurane & Dexmedetomidi, N1 group: Isoflurane & saline, N2 group: Isoflurane & Dexmedetomidine |
| Isofluraneinhale Isoflurane 1.5MAC | Drug | D1 group: Isoflurane & saline, D2 group: Isoflurane & Dexmedetomidi, N1 group: Isoflurane & saline, N2 group: Isoflurane & Dexmedetomidine |
| Dexmedetomidineanesthesia induction period: intravenous pumping Dexmedetomidine 4ug/Kg/h; after 10 minutes,turn to 0.4ug/Kg/h. | Drug | D2 group: Isoflurane & Dexmedetomidi, N2 group: Isoflurane & Dexmedetomidine |
| normal salinethe same volume of saline + Isoflurane during operation | Drug | D1 group: Isoflurane & saline, N1 group: Isoflurane & saline |
Primary outcome
blood glucose
Time frame: from the day before surgery to 24 hours after surgery
measure blood glucose at 3 time points,the day before surgery,Intraoperative(1 hour after surgery begain),one day after surgery(24 hours after surgery); examine the concentration of blood glucose in serum.
level of blood insulin
Time frame: from the day before surgery to 24 hours after surgery
measure the level of blood insulin at 3 time points,the day before surgery,Intraoperative(1 hour after surgery begain),one day after surgery(24 hours after surgery); use ELISA to examine the concentration of blood insulin in serum.
1 secondary outcome
vital signs
Time frame: duration of perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing general anesthesia induction, Isoflurane and Dexmedetomidine in people with Perioperative Blood Glucose and Insulin, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Jun 2014. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongtao Liu (13572225310, lannylouis@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose (time frame: from the day before surgery to 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2014.