Type 2 Diabetes Mellitus (T2DM)NCT06613893
Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose in Type 2 Diabetes Patients
A study testing TIVA and Inhalational anesthesia in people with Type 2 Diabetes Mellitus (T2DM) and Thoracic Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia (IHA) as maintenance anesthesia on blood glucose level and complications in type 2 diabetic patients undergoing thoracic surgery . Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Thoracic Surgery
- What is being tested?
- TIVA and Inhalational anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 - 70 years
- Sex: Both sexes
- Patients with type 2 diabetes mellitus controlled with oral hypoglycemic drugs
- Patients with ASA classification II,III
- Duration of surgery (≥2 h)
Who cannot join
- Declining to give written informed consent
- ASA classification Ⅳ to V
- Severe systemic diseases
- Metabolic disorders, diabetic ketoacidosis or hyperglycemia (fasting blood Glucose more than 140 mg/dl)
- Hepatic and/or renal dysfunction
- Neuromuscular disease
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- Pancreatic cancer
- History of malignant hyperthermia
- Emergency surgery
- Ischemic heart disease and valvular heart disease
- Body mass index more than 40
- Diabetic patients on insulin therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose Level in Type 2 Diabetes Mellitus Patients Undergoing Thoracic Surgery : a Comparative Study
The aim of this study is to compare the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia (IHA) as maintenance anesthesia on blood glucose level and complications in type 2 diabetic patients undergoing thoracic surgery . All participants had to understand and give written informed consent , and ethical committee approval (of Faculty of Medicine, Ain Shams University) will be obtained before participants allocation.
Read the detailed description
- Type of Study: prospective , randomized .
- Study Settings: Ain Shams University hospitals, Cairo, Egypt.
- Study period: 12 months starting from janurary 2024 .
- Study Population: All adult type 2 diabetic patients (30-70 year old) with class II,III based on the American Society of Anesthesiologists (ASA) physical status undergoing elective thoracic surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes:
- Group A will receive total inravenous anesthesia (TIVA).
- Group B will receive inhalational anesthesia (IHA)
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Thoracic Surgery
- Being tested
- TIVA, Inhalational anesthesia
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVADrug
Also called Fentanyl, propofol
Anesthesia will be maintained by total intravenous anesthesia with propofol infusion (4 to 12 mcg/kg/min) and fentanyl infusion (1-2mcg /kg/hour) that will be stopped 30 min before the end of the operation ,The heart rate and blood pressure will be maintained within the range of ±20% of the baseline
Inhalational anesthesiaDrug
Anesthesia will be maintained with inhaled isoflurane, Iso-MAC from (0.7 to 1.4%)(Hawkley, Preston, and Maani 2018) and fentanyl infusion (1-2mcg /kg/hour) that will be stopped 30 min before the end of the operation ,The heart rate and blood pressure will be maintained within the range of ±20% of the baseline
| Study group | Role | What they receive |
|---|---|---|
| Group A will receive total inravenous anesthesia (TIVA) | Active comparator | patients in this group will receive total intravenous anesthesia using propofol infusion after induction of anesthesia, tested variables will be measured according to the protocol |
| Group B will receive inhalational anesthesia (IHA) | Active comparator | patients in this group will receive inhalational anesthesia using isoflurane, tested variables will be measured according to the protocol Receives: Drug: Inhalational anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose levels in milligrams per decilitre (mg/dl) at different time points
Blood glucose levels in milligrams per deciliter at different time points: preoperative (T0), post-intubation (T1), 1st , 2nd and 3rd hour after the start of the operation (T3, T4 and T5, respectively), 1st hour after the operation (T6) , 2nd hour after the operation (T7), 1st and 2nd day after the operation (T8, T9)
Measured: Immediate preoperative till 48 hours after recovery from anesthesia
Secondary outcomes (3)
Serum insulin level in picomoles per litre (pmol/l)
serum insulin level (pmol/l) 30 min before and 30 min after surgery
Measured: 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia
Serum cortisol level in micrograms per decilitre (mcg/dl)
serum cortisol level (mcg/dl) 30 min before and 30 min after surgery
Measured: 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia
The incidence of postoperative complications
The complications that will be tested Acute coronary syndrome. Stroke. acute kidney injury. stress gastric ulcer. surgical site infection. Hypoglycaemia (blood glucose level below 70 mg/dL). Hyperglycemia (fasting blood glucose level greater than 125mg/dL while 2 hours postprandial greater than 200 mg/dL).
Postoperative nausea and vomiting . postoperative pulmonary complications including atelectasis, pneumonia and respiratory failure
Measured: The complications will be assessed on the first, third and seveth post-operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Alaa Abdalmonim, Ain Shams University
- Investigators
- Nabila M Abdelaziz, professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613893
- Sponsor's protocol ID
- FMASU@MD331/2023
- Status last verified
- May 2025
- First submitted
- 6 Sep 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose Level in Type 2 Diabetes Mellitus Patients Undergoing Thoracic Surgery : a Comparative Study
- ClinicalTrials.gov ID
- NCT06613893
- Acronym / sponsor ID
- FMASU@MD331/2023
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Sep 2024 (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 aim of this study is to compare the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia (IHA) as maintenance anesthesia on blood glucose level and complications in type 2 diabetic patients undergoing thoracic surgery . All participants had to understand and give written informed consent , and ethical committee approval (of Faculty of Medicine, Ain Shams University) will be obtained before participants allocation.
Detailed description
- Type of Study: prospective , randomized .
- Study Settings: Ain Shams University hospitals, Cairo, Egypt.
- Study period: 12 months starting from janurary 2024 .
- Study Population: All adult type 2 diabetic patients (30-70 year old) with class II,III based on the American Society of Anesthesiologists (ASA) physical status undergoing elective thoracic surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes:
- Group A will receive total inravenous anesthesia (TIVA).
- Group B will receive inhalational anesthesia (IHA)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A will receive total inravenous anesthesia (TIVA) | Active comparator | –patients in this group will receive total intravenous anesthesia using propofol infusion after induction of anesthesia, tested variables will be measured according to the protocol |
| Group B will receive inhalational anesthesia (IHA) | Active comparator | Drug: Inhalational anesthesiapatients in this group will receive inhalational anesthesia using isoflurane, tested variables will be measured according to the protocol |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30 - 70 years
- Sex: Both sexes
- Patients with type 2 diabetes mellitus controlled with oral hypoglycemic drugs
- Patients with ASA classification II,III
- Duration of surgery (≥2 h)
Key exclusion criteria (12 listed)
- Declining to give written informed consent
- ASA classification Ⅳ to V
- Severe systemic diseases
- Metabolic disorders, diabetic ketoacidosis or hyperglycemia (fasting blood Glucose more than 140 mg/dl)
- Hepatic and/or renal dysfunction
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: Fentanyl, propofolAnesthesia will be maintained by total intravenous anesthesia with propofol infusion (4 to 12 mcg/kg/min) and fentanyl infusion (1-2mcg /kg/hour) that will be stopped 30 min before the end of the operation ,The heart rate and blood pressure will be maintained within the range of ±20% of the baseline | Drug | – |
| Inhalational anesthesiaAnesthesia will be maintained with inhaled isoflurane, Iso-MAC from (0.7 to 1.4%)(Hawkley, Preston, and Maani 2018) and fentanyl infusion (1-2mcg /kg/hour) that will be stopped 30 min before the end of the operation ,The heart rate and blood pressure will be maintained within the range of ±20% of the baseline | Drug | Group B will receive inhalational anesthesia (IHA) |
Primary outcome
Blood glucose levels in milligrams per decilitre (mg/dl) at different time points
Time frame: Immediate preoperative till 48 hours after recovery from anesthesia
Blood glucose levels in milligrams per deciliter at different time points: preoperative (T0), post-intubation (T1), 1st , 2nd and 3rd hour after the start of the operation (T3, T4 and T5, respectively), 1st hour after the operation (T6) , 2nd hour after the operation (T7), 1st and 2nd day after the operation (T8, T9)
3 secondary outcomes
Serum insulin level in picomoles per litre (pmol/l)
Time frame: 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia
Serum cortisol level in micrograms per decilitre (mcg/dl)
Time frame: 30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia
The incidence of postoperative complications
Time frame: The complications will be assessed on the first, third and seveth post-operative day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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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.
Nabila M Abdelaziz, professor study director
Ain Shams University
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 Inhalational anesthesia in people with Type 2 Diabetes Mellitus (T2DM) and Thoracic Surgery, run by Ain Shams University at 1 site in Egypt.
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 12 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Blood glucose levels in milligrams per decilitre (mg/dl) at different time points (time frame: Immediate preoperative till 48 hours after recovery from anesthesia). 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 29 May 2025.