Total Intravenous AnesthesiaPhase 4NCT06024733
Intravenous Anesthesia by Targeted Controlled Infusion Versus Inhalational Anesthesia on the Surgical Stress Response
A Phase 4 study testing Sevoflurane in people with Total Intravenous Anesthesia and Inhalational Anesthesia, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to compare the effect of total Intravenous anesthesia Target-controlled infusion (TIVA-TCI) with inhalational anesthesia on stress response. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Total Intravenous Anesthesia, Inhalational Anesthesia, Surgical Stress Response
- What is being tested?
- Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Oct 2023to 1 Dec 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients subjected to lower abdominal cancer surgery.
- Patients of both sexes
- body mass index < 35 kg/m2.
- Age from 18 to 60 years.
- ASA, I-II.
Who cannot join
- Patients with a history of severe cardiovascular or respiratory disease.
- Severe hepatic, renal, or neurological diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Total Intravenous Anesthesia by Targeted Controlled Infusion on Surgical Stress Response Compared to Inhalational Anesthesia
This study aims to compare the effect of total Intravenous anesthesia Target-controlled infusion (TIVA-TCI) with inhalational anesthesia on stress response.
Read the detailed description
Target-controlled infusion (TCI) techniques have been used to induce and maintain general anesthesia or to provide computer-assisted personalized sedation. Target-controlled infusion (TCI) systems are computer-assisted IV infusion pumps that use pharmacokinetic and pharmacodynamic mathematical modeling to maintain a user-designated target concentration at an effect site (typically the brain).
The clinician enters a desired target concentration for an anesthetic or another agent. The computer calculates the amount of the agent required to achieve the target concentration at the effect site and directs an infusion pump to deliver the calculated boluses or infusions. Therefore, TIVA-TCI allows a more stable hemodynamic profile during surgery, prevents long-acting opioid-induced accumulation and allows rapid recovery from general anesthesia.
Total intravenous anaesthesia (TIVA) regimen with Propofol is a useful anaesthetic technique, effectively controlling responses to tracheal intubation and intense surgical stimulation, while avoiding Inhalational anaesthetics and allowing rapid emergence from anaesthesia .
- Conditions
- Total Intravenous Anesthesia, Inhalational Anesthesia, Surgical Stress Response, Target-controlled Infusion
- Being tested
- Sevoflurane, Target Controlled Infusion, Target Controlled Infusion and lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called group 1
patient recieve propofol for induction and sevoflurane for maintenance
Target Controlled InfusionDrug
Also called GROUP 2
target controlled infusion of propofol
Target Controlled Infusion and lidocaineDrug
Also called GROUP3
patients will receive total intravenous anesthesia with propofol Target Controlled Infusion. At the induction of anesthesia, the patients will receive a bolus of lidocaine 1% 1.5 mg/kg and a continuous infusion of lidocaine 1% 2 mg/kg/h will be associated throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| inhalational | Sham comparator | Not described Receives: Drug: Sevoflurane |
| Target Controlled Infusion | Active comparator | Not described Receives: Drug: Target Controlled Infusion |
| Target Controlled Infusion and lidocaine | Active comparator | Not described Receives: Drug: Target Controlled Infusion and lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of the stress response by serum level of insulin-like growth factors
The serum level of insulin-like growth factors will be measured at preoperative, intraoperative after one hour of intubation, at the end of surgery and after extubation, and transfer to the intensive care unit.
Measured: Intraoperative and 24hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start7 Oct 2023
- Primary completion1 Aug 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Intravenous AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ali Galal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024733
- Sponsor's protocol ID
- 525
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Intravenous Anesthesia by Targeted Controlled Infusion on Surgical Stress Response Compared to Inhalational Anesthesia
- ClinicalTrials.gov ID
- NCT06024733
- Acronym / sponsor ID
- 525
- Conditions
- Total Intravenous Anesthesia, Inhalational Anesthesia, Surgical Stress Response, Target-controlled Infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Sep 2023 (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.
This study aims to compare the effect of total Intravenous anesthesia Target-controlled infusion (TIVA-TCI) with inhalational anesthesia on stress response.
Detailed description
Target-controlled infusion (TCI) techniques have been used to induce and maintain general anesthesia or to provide computer-assisted personalized sedation. Target-controlled infusion (TCI) systems are computer-assisted IV infusion pumps that use pharmacokinetic and pharmacodynamic mathematical modeling to maintain a user-designated target concentration at an effect site (typically the brain).
The clinician enters a desired target concentration for an anesthetic or another agent. The computer calculates the amount of the agent required to achieve the target concentration at the effect site and directs an infusion pump to deliver the calculated boluses or infusions. Therefore, TIVA-TCI allows a more stable hemodynamic profile during surgery, prevents long-acting opioid-induced accumulation and allows rapid recovery from general anesthesia.
Total intravenous anaesthesia (TIVA) regimen with Propofol is a useful anaesthetic technique, effectively controlling responses to tracheal intubation and intense surgical stimulation, while avoiding Inhalational anaesthetics and allowing rapid emergence from anaesthesia .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| inhalational | Sham comparator | Drug: Sevoflurane |
| Target Controlled Infusion | Active comparator | Drug: Target Controlled Infusion |
| Target Controlled Infusion and lidocaine | Active comparator | Drug: Target Controlled Infusion and lidocaine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients subjected to lower abdominal cancer surgery.
- Patients of both sexes
- body mass index < 35 kg/m2.
- Age from 18 to 60 years.
- ASA, I-II.
Key exclusion criteria (2 listed)
- Patients with a history of severe cardiovascular or respiratory disease.
- Severe hepatic, renal, or neurological diseases.
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 |
|---|---|---|
| SevofluraneAlso: group 1patient recieve propofol for induction and sevoflurane for maintenance | Drug | inhalational |
| Target Controlled InfusionAlso: GROUP 2target controlled infusion of propofol | Drug | Target Controlled Infusion |
| Target Controlled Infusion and lidocaineAlso: GROUP3patients will receive total intravenous anesthesia with propofol Target Controlled Infusion. At the induction of anesthesia, the patients will receive a bolus of lidocaine 1% 1.5 mg/kg and a continuous infusion of lidocaine 1% 2 mg/kg/h will be associated throughout the procedure. | Drug | Target Controlled Infusion and lidocaine |
Primary outcome
The level of the stress response by serum level of insulin-like growth factors
Time frame: Intraoperative and 24hours after surgery
The serum level of insulin-like growth factors will be measured at preoperative, intraoperative after one hour of intubation, at the end of surgery and after extubation, and transfer to the intensive care unit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sevoflurane in people with Total Intravenous Anesthesia and Inhalational Anesthesia, run by Assiut 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 2 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 13 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
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 level of the stress response by serum level of insulin-like growth factors (time frame: Intraoperative and 24hours after surgery). 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 13 Aug 2024.