Laparoscopic Sleeve GastrectomyNCT06423846
Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function
A study testing Total intravenous anesthesia group and sevoflurane group in people with Laparoscopic Sleeve Gastrectomy, run by Benha University at 1 site in Egypt.
Trial summary
The pandemic of obesity has become a serious issue of public health worldwide as the size of the obese population has almost tripled over the last four decades and continues to riseزThe epidemic of obesity has led to a significant increase in the prevalence of non-alcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy
- What is being tested?
- Total intravenous anesthesia group and sevoflurane group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2024to 12 May 2024
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patients
- had ASA I-III
- diagnosed with non-alcoholic steatohepatitis (NASH) liver disease
- undergoing laparoscopic sleeve gastrectomy
Who cannot join
- cases wherein surgeries were performed using anesthetic methods that were not clearly identified as TIVA or INHA
- heart surgery or cesarean section, and cases of neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function in Patients With Non-Alcoholic Steatohepatitis Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Clinical Trial
The pandemic of obesity has become a serious issue of public health worldwide as the size of the obese population has almost tripled over the last four decades and continues to riseزThe epidemic of obesity has led to a significant increase in the prevalence of non-alcoholic fatty liver disease (NAFLD). NAFLD is currently the most common chronic liver disease, with an estimated global prevalence at 25-30%, rising up to 90% in morbidly obese patients
Read the detailed description
Anesthesia and surgery may deteriorate liver function in patients with elevated liver enzyme levels; therefore, in these patients, choosing anaesthetics with less hepatotoxicity may be important. Halothane, which is a typical inhalational anesthetic, is known for its liver and kidney toxicity. The latest anesthetic agents, including sevoflurane and desflurane, are associated with less hepatotoxicity, although rare cases of acute liver injury have been reported with these agentsزPropofol (2,6-diisopropylphenol) is an intravenous anesthetic. Its pharmacokinetic profile makes it very suitable for total intravenous anesthesia (TIVA) and this is a widely used technique in many centers. Its use results in a rapid onset and offset with fewer side effects including postoperative nausea and vomiting, making it particularly favorable in the ambulatory setting
- Conditions
- Laparoscopic Sleeve Gastrectomy
- Being tested
- Total intravenous anesthesia group, sevoflurane group
- Keywords
- Total Intravenous Anesthesia, Inhalation Anesthesia, Laparoscopic Sleeve Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total intravenous anesthesia groupDrug
Also called TIVA group
Patients in the TIVA group had anesthesia induced with propofol 2 mg/kg , fentanyl 1 ug/kg and maintained with propofol. 200 ug/kg/min, fentanyl 0.1ug/kg/min, dexmedetomidine 1 ug/kg/hour
sevoflurane groupDrug
Also called SEVO group
For patients in the SEVO group, general anesthesia was induced with propofol 2 mg/kg, fentanyl 1 ug/kg and then maintained with sevoflurane in air and oxygen, dexmedetomidine 1 ug/kg/hour.
| Study group | Role | What they receive |
|---|---|---|
| total intravenous anesthesia group | Experimental | Patients in the TIVA group had anesthesia induced with propofol 2 mg/kg , fentanyl 1 ug/kg and maintained with propofol. Receives: Drug: Total intravenous anesthesia group |
| sevoflurane group | Experimental | general anesthesia was induced with propofol 2 mg/kg, fentanyl 1 ug/kg and then maintained with sevoflurane in air and oxygen, dexmedetomidine 1 ug/kg/hour. Receives: Drug: sevoflurane group |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
Pain was assessed by using the visual analogue scale (VAS) score for pain (0-no pain, 10-worst imaginable pain)
Measured: visual analogue scale was measured at day one and day two postoperatively
Secondary outcomes (1)
Patient satisfaction
5-point Likert scale, (1=extremely dissatisfied; 5=extremely satisfied)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start26 Jan 2024
- Primary completion6 May 2024
- Study completion12 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Sleeve GastrectomyStudies 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
- Model description
- The participants were randomized into two equal groups using a computer-generated list of random numbers sealed in an opaque envelope and were randomly allocated into two groups on a scale of 1:1.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Mousa, Benha University
- Investigators
- Ramy Saleh, MD, Principal investigator, Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423846
- Sponsor's protocol ID
- RC-3-4-2024
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmed OT, Gidener T, Mara KC, Larson JJ, Therneau TM, Allen AM. Natural History of Nonalcoholic Fatty Liver Disease With Normal Body Mass Index: A Population-Based Study. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1374-1381.e6. doi: 10.1016/j.cgh.2021.07.016. Epub 2021 Jul 13.
PubMed 34265444
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function in Patients With Non-Alcoholic Steatohepatitis Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06423846
- Acronym / sponsor ID
- RC-3-4-2024
- Conditions
- Laparoscopic Sleeve Gastrectomy
- Keywords
- Total Intravenous Anesthesia, Inhalation Anesthesia, Laparoscopic Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 12 May 2024 (actual)
- First posted
- 21 May 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 pandemic of obesity has become a serious issue of public health worldwide as the size of the obese population has almost tripled over the last four decades and continues to riseزThe epidemic of obesity has led to a significant increase in the prevalence of non-alcoholic fatty liver disease (NAFLD). NAFLD is currently the most common chronic liver disease, with an estimated global prevalence at 25-30%, rising up to 90% in morbidly obese patients
Detailed description
Anesthesia and surgery may deteriorate liver function in patients with elevated liver enzyme levels; therefore, in these patients, choosing anaesthetics with less hepatotoxicity may be important. Halothane, which is a typical inhalational anesthetic, is known for its liver and kidney toxicity. The latest anesthetic agents, including sevoflurane and desflurane, are associated with less hepatotoxicity, although rare cases of acute liver injury have been reported with these agentsزPropofol (2,6-diisopropylphenol) is an intravenous anesthetic. Its pharmacokinetic profile makes it very suitable for total intravenous anesthesia (TIVA) and this is a widely used technique in many centers. Its use results in a rapid onset and offset with fewer side effects including postoperative nausea and vomiting, making it particularly favorable in the ambulatory setting
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were randomized into two equal groups using a computer-generated list of random numbers sealed in an opaque envelope and were randomly allocated into two groups on a scale of 1:1.
| Arm | Type | Receives |
|---|---|---|
| total intravenous anesthesia group | Experimental | Drug: Total intravenous anesthesia groupPatients in the TIVA group had anesthesia induced with propofol 2 mg/kg , fentanyl 1 ug/kg and maintained with propofol. |
| sevoflurane group | Experimental | Drug: sevoflurane groupgeneral anesthesia was induced with propofol 2 mg/kg, fentanyl 1 ug/kg and then maintained with sevoflurane in air and oxygen, dexmedetomidine 1 ug/kg/hour. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obese patients
- had ASA I-III
- diagnosed with non-alcoholic steatohepatitis (NASH) liver disease
- undergoing laparoscopic sleeve gastrectomy
Key exclusion criteria (2 listed)
- cases wherein surgeries were performed using anesthetic methods that were not clearly identified as TIVA or INHA
- heart surgery or cesarean section, and cases of neuromuscular 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 |
|---|---|---|
| Total intravenous anesthesia groupAlso: TIVA groupPatients in the TIVA group had anesthesia induced with propofol 2 mg/kg , fentanyl 1 ug/kg and maintained with propofol. 200 ug/kg/min, fentanyl 0.1ug/kg/min, dexmedetomidine 1 ug/kg/hour | Drug | total intravenous anesthesia group |
| sevoflurane groupAlso: SEVO groupFor patients in the SEVO group, general anesthesia was induced with propofol 2 mg/kg, fentanyl 1 ug/kg and then maintained with sevoflurane in air and oxygen, dexmedetomidine 1 ug/kg/hour. | Drug | sevoflurane group |
Primary outcome
visual analogue scale
Time frame: visual analogue scale was measured at day one and day two postoperatively
Pain was assessed by using the visual analogue scale (VAS) score for pain (0-no pain, 10-worst imaginable pain)
1 secondary outcome
Patient satisfaction
Time frame: 24 hours postoperatively
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 21 May 2024.
- Background: PubMed 34265444Ahmed OT, Gidener T, Mara KC, Larson JJ, Therneau TM, Allen AM. Natural History of Nonalcoholic Fatty Liver Disease With Normal Body Mass Index: A Population-Based Study. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1374-1381.e6. doi: 10.1016/j.cgh.2021.07.016. Epub 2021 Jul 13.
- 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.
Ramy Saleh, MD principal investigator
Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total intravenous anesthesia group and sevoflurane group in people with Laparoscopic Sleeve Gastrectomy, run by Benha 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 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: finished, as of the sponsor's last update on 21 May 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. 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?
visual analogue scale (time frame: visual analogue scale was measured at day one and day two postoperatively). 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 NCT06423846, which also lists 1 linked publication.
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 21 May 2024.