Diabete MellitusPhase 4NCT07496593
Total Intravenous and Balanced Anesthesia in Diabetic Patients Undergoing Video-Assisted Thoracoscopy
A Phase 4 study testing Propofol + fentanyl + Atracurium and Isoflurane and Atracurium in people with Diabete Mellitus and VATS, run by Ain Shams University at 1 site in Egypt.
Trial summary
Video-assisted thoracoscopy is a minimally invasive surgical technique used to diagnose and treat problems in chest. Diabetics are more prone to infections, slower wound healing and other complications during and after surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabete Mellitus, VATS, TIVA
- What is being tested?
- Propofol + fentanyl + Atracurium and Isoflurane and Atracurium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient for both sex scheduled for VATS.
- Age group 18-70 years.
- Diagnosed diabetes mellitus (Type 1 or 2) HbA1c 6-8 % within 3 months.
- ASA II and III.
Who cannot join
- HbA1c > 8 % or < 6 or preoperative insulin infusion or DKA within 3 months
- Emergency surgery.
- Drug allergy.
- Chronic high-dose steroids.
- Severe hepatic/ renal impairment, significant arrhythmia or severe LV dysfunction.
- Patient refusal.
- Psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Total Intravenous Anesthesia (TIVA) Versus Balanced Anesthesia in Diabetic Patients Undergoing Video-Assisted Thoracoscopy.
Video-assisted thoracoscopy is a minimally invasive surgical technique used to diagnose and treat problems in chest. Diabetics are more prone to infections, slower wound healing and other complications during and after surgery. Studies suggests that Total Intravenous Anesthesia (TIVA) can lead to a lower increase in blood glucose levels and a better suppression of the stress response compared to balanced anesthesia using inhalational agents like Isoflurane.
In the present study we are aiming to compare the effects of Total Intravenous Anesthesia (TIVA) Versus Balanced Anesthesia on blood glucose level in Diabetic Patients undergoing Video-assisted thoracoscopy.
Read the detailed description
The aim of the study is to assess the impact of total intravenous anesthesia and balanced anesthesia as anesthesia maintenance approach on blood glucose level and postoperative complications in diabetic patients undergoing video-assisted thoracoscopy All patients will be kept fasting for 2 hours for clear fluids and 6 hours for meals preoperatively . Oral antidiabetic medications were continued in diabetic patients on the day before surgery, and were discontinued on the day of surgery. The doses of long-acting insulin administered should be reduced by 50-75% on the night before surgery to avoid hypoglycemia during a prolonged fast. Half doses of basal insulin were administered the morning of surgery. Blood glucose level is measured, if hyperglycemia occurred, control of hyperglycemia is done by giving regular insulin. A detailed history, thorough general and physical examination and routine investigations will be done. Patients fulfilling inclusion criteria will be randomly divided into two groups using computer generated random numbers with (30) patients in each group. Group A will receive Total intravenous anesthesia (TIVA). Group B will receive Balanced anesthesia.
Upon arrival to the operating room, standard monitoring including pulse oximetry (spo2), continuous electrocardiogram (ECG) and noninvasive blood pressure (BP) measurement and capnography will be started. Blood glucose level will be measured then a proper sized intravenous access will be inserted under complete aseptic conditions and secured. Blood sample for cortisol will be taken. Midazolam 0.02-0.07 mg/ kg will be given for sedation before induction of anesthesia. An intravenous drip of Ringer lactate will be initiated at a rate of 1-2 ml/kg/h as maintenance fluid and replacement fluid will also be given for fasting which is half of the deficit in the first hour of surgery then quarter of the deficit for the rest of surgery. Fluid deficit is the maintenance rate multiplied by the hours of fasting. Glucocorticoid drugs and nonsteroidal analgesics will not be allowed during the surgery. After proper pre-oxygenation general anesthesia will be induced intravenously by propofol 1.5-2.5 mg /kg, fentanyl1-2 mic / kg and atracurium 0.4-0.5 mg / kg in both groups. Endotracheal tube will be placed and secured. Blood glucose level will be measured.
For patients receiving TIVA (Group A) anesthesia will be maintained with propofol infusion (4-12 mg/kg/h), Fentanyl infusion (1-2 mic /kg/h) and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes.
For patients receiving balanced anesthesia (Group B) anesthesia will be maintained with isoflurane 1.5% and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes.
The maintenance of anesthesia in both groups will be performed using volume controlled ventilation with oxygen (100%), tidal volume 5-7 ml /kg for ideal body weight, rate is adjusted to maintain normocapnia.
- Conditions
- Diabete Mellitus, VATS, TIVA
- Being tested
- Propofol + fentanyl + Atracurium, Isoflurane and Atracurium
- Keywords
- Diabetes, VATS, TIVA
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol + fentanyl + AtracuriumDrug
Group A (TIVA) will not receive any inhaled anesthesia
Isoflurane and AtracuriumDrug
Group B will receive inhaled anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Propofol, Fentanyl and Atracurium | Active comparator | For patients receiving TIVA (Group A) anesthesia will be maintained with Propofol infusion (4-12 mg/kg/h), Fentanyl infusion (1-2 mic /kg/h) and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes. Receives: Drug: Propofol + fentanyl + Atracurium |
| Isoflurane and atracurium | Active comparator | patients receiving balanced anesthesia (Group B) anesthesia will be maintained with isoflurane 1.5% and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes. Receives: Drug: Isoflurane and Atracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study will be blood glucose level after one and half hour
measurement of blood gulcose level
Measured: one and half hour
Secondary outcomes (1)
blood glucose level and blood cortisol levels . Also the occurrence of postoperative nausea and vomiting, emergence agitation, postoperative laryngospasm and stridor and postoperative pain.
measurement of blood glucose level and blood cortisol level
Measured: blood glucose level 5 mins after (intubation, extubation, admission to PACU ) and after 2 hours and then every 4 hours for 24 hours. blood cortisol level 5 mins before induction of anesthesia, after one and half hour and then every 4 hours for 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aisha Galal El Din Soliman Said Ahmed Donia, Ain Shams University
- Investigators
- Nahed Effat, professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496593
- Sponsor's protocol ID
- FMASU MD305/2025
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Total Intravenous Anesthesia (TIVA) Versus Balanced Anesthesia in Diabetic Patients Undergoing Video-Assisted Thoracoscopy.
- ClinicalTrials.gov ID
- NCT07496593
- Acronym / sponsor ID
- FMASU MD305/2025
- Conditions
- Diabete Mellitus, VATS, TIVA
- Keywords
- Diabetes, VATS, TIVA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (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.
Video-assisted thoracoscopy is a minimally invasive surgical technique used to diagnose and treat problems in chest. Diabetics are more prone to infections, slower wound healing and other complications during and after surgery. Studies suggests that Total Intravenous Anesthesia (TIVA) can lead to a lower increase in blood glucose levels and a better suppression of the stress response compared to balanced anesthesia using inhalational agents like Isoflurane.
In the present study we are aiming to compare the effects of Total Intravenous Anesthesia (TIVA) Versus Balanced Anesthesia on blood glucose level in Diabetic Patients undergoing Video-assisted thoracoscopy.
Detailed description
The aim of the study is to assess the impact of total intravenous anesthesia and balanced anesthesia as anesthesia maintenance approach on blood glucose level and postoperative complications in diabetic patients undergoing video-assisted thoracoscopy All patients will be kept fasting for 2 hours for clear fluids and 6 hours for meals preoperatively . Oral antidiabetic medications were continued in diabetic patients on the day before surgery, and were discontinued on the day of surgery. The doses of long-acting insulin administered should be reduced by 50-75% on the night before surgery to avoid hypoglycemia during a prolonged fast. Half doses of basal insulin were administered the morning of surgery. Blood glucose level is measured, if hyperglycemia occurred, control of hyperglycemia is done by giving regular insulin. A detailed history, thorough general and physical examination and routine investigations will be done. Patients fulfilling inclusion criteria will be randomly divided into two groups using computer generated random numbers with (30) patients in each group. Group A will receive Total intravenous anesthesia (TIVA). Group B will receive Balanced anesthesia.
Upon arrival to the operating room, standard monitoring including pulse oximetry (spo2), continuous electrocardiogram (ECG) and noninvasive blood pressure (BP) measurement and capnography will be started. Blood glucose level will be measured then a proper sized intravenous access will be inserted under complete aseptic conditions and secured. Blood sample for cortisol will be taken. Midazolam 0.02-0.07 mg/ kg will be given for sedation before induction of anesthesia. An intravenous drip of Ringer lactate will be initiated at a rate of 1-2 ml/kg/h as maintenance fluid and replacement fluid will also be given for fasting which is half of the deficit in the first hour of surgery then quarter of the deficit for the rest of surgery. Fluid deficit is the maintenance rate multiplied by the hours of fasting. Glucocorticoid drugs and nonsteroidal analgesics will not be allowed during the surgery. After proper pre-oxygenation general anesthesia will be induced intravenously by propofol 1.5-2.5 mg /kg, fentanyl1-2 mic / kg and atracurium 0.4-0.5 mg / kg in both groups. Endotracheal tube will be placed and secured. Blood glucose level will be measured.
For patients receiving TIVA (Group A) anesthesia will be maintained with propofol infusion (4-12 mg/kg/h), Fentanyl infusion (1-2 mic /kg/h) and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes.
For patients receiving balanced anesthesia (Group B) anesthesia will be maintained with isoflurane 1.5% and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes.
The maintenance of anesthesia in both groups will be performed using volume controlled ventilation with oxygen (100%), tidal volume 5-7 ml /kg for ideal body weight, rate is adjusted to maintain normocapnia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol, Fentanyl and Atracurium | Active comparator | Drug: Propofol + fentanyl + AtracuriumFor patients receiving TIVA (Group A) anesthesia will be maintained with Propofol infusion (4-12 mg/kg/h), Fentanyl infusion (1-2 mic /kg/h) and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes. |
| Isoflurane and atracurium | Active comparator | Drug: Isoflurane and Atracuriumpatients receiving balanced anesthesia (Group B) anesthesia will be maintained with isoflurane 1.5% and atracurium 0.1 - 0.2 mg / kg every 20-30 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient for both sex scheduled for VATS.
- Age group 18-70 years.
- Diagnosed diabetes mellitus (Type 1 or 2) HbA1c 6-8 % within 3 months.
- ASA II and III.
Key exclusion criteria (7 listed)
- HbA1c > 8 % or < 6 or preoperative insulin infusion or DKA within 3 months
- Emergency surgery.
- Drug allergy.
- Chronic high-dose steroids.
- Severe hepatic/ renal impairment, significant arrhythmia or severe LV 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 |
|---|---|---|
| Propofol + fentanyl + AtracuriumGroup A (TIVA) will not receive any inhaled anesthesia | Drug | Propofol, Fentanyl and Atracurium |
| Isoflurane and AtracuriumGroup B will receive inhaled anesthesia | Drug | Isoflurane and atracurium |
Primary outcome
The primary outcome of this study will be blood glucose level after one and half hour
Time frame: one and half hour
measurement of blood gulcose level
1 secondary outcome
blood glucose level and blood cortisol levels . Also the occurrence of postoperative nausea and vomiting, emergence agitation, postoperative laryngospasm and stridor and postoperative pain.
Time frame: blood glucose level 5 mins after (intubation, extubation, admission to PACU ) and after 2 hours and then every 4 hours for 24 hours. blood cortisol level 5 mins before induction of anesthesia, after one and half hour and then every 4 hours for 24 hours.
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 27 Mar 2026.
- Individual participant dataSharing planned: Yes
Related trials for Diabete Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Nahed Effat, professor study chair
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 Phase 4 study testing Propofol + fentanyl + Atracurium and Isoflurane and Atracurium in people with Diabete Mellitus and VATS, 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 4 inclusion and 7 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 27 Mar 2026. 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.
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?
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?
The primary outcome of this study will be blood glucose level after one and half hour (time frame: one and half hour). 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 27 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.