Obesity, MorbidNCT05170711
Hypotensive Anesthesia With Sleeve Gastrectomy
A study testing hypotensive anesthesia and normotensive anesthesia in people with Obesity, Morbid, run by Minia University at 1 site in Egypt.
Trial summary
to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- hypotensive anesthesia and normotensive anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2021to 3 May 2022
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obese patients with BMI more than 40 or more than 35 with comorbidity
- patients fit for laparoscopic surgery
- give approval to share in the study
Who cannot join
- patients refused to share in the study
- patients unfit for surgery
- patients aged less than 18 and older than 50
- patients with BMI less than 35
- patient with previous upper abdominal surgery either for obesity or other diseases
- patients with GERD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Hypotensive Anesthesia With Sleeve Gastrectomy
to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end
Read the detailed description
to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end of the operation to check bleeding
- Conditions
- Obesity, Morbid
- Being tested
- hypotensive anesthesia, normotensive anesthesia
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypotensive anesthesiaProcedure or surgery
hypotensive anesthesia
normotensive anesthesiaProcedure or surgery
normotensive anesthesia group
| Study group | Role | What they receive |
|---|---|---|
| hypotensive anesthesia | Experimental | hypotensive anesthesia group Receives: Procedure: hypotensive anesthesia |
| normotensive anesthesia | Active comparator | normotensive anesthesia group Receives: Procedure: normotensive anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
operative time from skin to skin
Measured: 20-120 minutes
intraoperative bleeding or oozing
intraoperative bleeding or oozing by the number of used gauzes and clips
Measured: 0-120 minute
Secondary outcomes (1)
postoperative bleeding
the incidence of postoperative bleeding
Measured: 2-36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start10 Dec 2021
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Minia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mstafa Hassan Sewefy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170711
- Sponsor's protocol ID
- Fac.med 21.50
- Status last verified
- May 2022
- First submitted
- 11 Dec 2021
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Hypotensive Anesthesia With Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT05170711
- Acronym / sponsor ID
- Fac.med 21.50
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 28 Dec 2021 (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.
to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end
Detailed description
to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end of the operation to check bleeding
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypotensive anesthesia | Experimental | Procedure: hypotensive anesthesiahypotensive anesthesia group |
| normotensive anesthesia | Active comparator | Procedure: normotensive anesthesianormotensive anesthesia group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- obese patients with BMI more than 40 or more than 35 with comorbidity
- patients fit for laparoscopic surgery
- give approval to share in the study
Key exclusion criteria (6 listed)
- patients refused to share in the study
- patients unfit for surgery
- patients aged less than 18 and older than 50
- patients with BMI less than 35
- patient with previous upper abdominal surgery either for obesity or other 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 |
|---|---|---|
| hypotensive anesthesiahypotensive anesthesia | Procedure or surgery | hypotensive anesthesia |
| normotensive anesthesianormotensive anesthesia group | Procedure or surgery | normotensive anesthesia |
Primary outcome
operative time
Time frame: 20-120 minutes
operative time from skin to skin
intraoperative bleeding or oozing
Time frame: 0-120 minute
intraoperative bleeding or oozing by the number of used gauzes and clips
1 secondary outcome
postoperative bleeding
Time frame: 2-36 hours
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 24 May 2022.
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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 study testing hypotensive anesthesia and normotensive anesthesia in people with Obesity, Morbid, run by Minia 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 3 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: finished, as of the sponsor's last update on 24 May 2022. 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?
operative time (time frame: 20-120 minutes). 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 24 May 2022.