Morbid ObesitySedBaloonNCT03747094
Sedation of Morbidly Obese for Balloon Insertion
A study testing Fentanyl and Ketamine in people with Morbid Obesity, run by Mansoura University at 1 site in Egypt.
Trial summary
This prospective study will assess the value of different supplements to orpofol bases anesthesia in morbidly obes e patients scheduled for balloon insertion. Two common drugs will be added to propofol bases anesthesia;Ketamine or fentanyl. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Fentanyl and Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 15 Apr 2019
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- morbid obese indicated for gastric balloon insertion
Who cannot join
- Refusal Hypersensitivity to any of the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fentanyl Versus Ketamine Supplementation for Prpofol Anesthesia During Balloon Insertion in Morbidly Obese Patients
This prospective study will assess the value of different supplements to orpofol bases anesthesia in morbidly obes e patients scheduled for balloon insertion. Two common drugs will be added to propofol bases anesthesia;Ketamine or fentanyl. Effect on prpofol consumption, post-procedure recovery profile, and patient satisfaction will be the study objectives.
- Conditions
- Morbid Obesity
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
0.5 mic/kg fentanyl will be given immediately before the procedure
KetamineDrug
0.25 mg ketamine will be administered immediately before the procedure
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl group | Active comparator | Not described Receives: Drug: Fentanyl |
| Ketamine group | Experimental | Not described Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol consumption (milligrams)
Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion
Measured: 24 hours after the endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion20 Mar 2019 (estimated)
- Study completion15 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747094
- Sponsor's protocol ID
- Sedation for balloon insertion
- Acronym
- SedBaloon
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Versus Ketamine Supplementation for Prpofol Anesthesia During Balloon Insertion in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT03747094
- Acronym / sponsor ID
- SedBaloon / Sedation for balloon insertion
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 20 Mar 2019 (estimated)
- Study completion
- 15 Apr 2019 (estimated)
- First posted
- 20 Nov 2018 (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 prospective study will assess the value of different supplements to orpofol bases anesthesia in morbidly obes e patients scheduled for balloon insertion. Two common drugs will be added to propofol bases anesthesia;Ketamine or fentanyl. Effect on prpofol consumption, post-procedure recovery profile, and patient satisfaction will be the study objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl group | Active comparator | Drug: Fentanyl |
| Ketamine group | Experimental | Drug: Ketamine |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- morbid obese indicated for gastric balloon insertion
Key exclusion criteria (1 listed)
- Refusal Hypersensitivity to any of the study drugs
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 |
|---|---|---|
| Fentanyl0.5 mic/kg fentanyl will be given immediately before the procedure | Drug | Fentanyl group |
| Ketamine0.25 mg ketamine will be administered immediately before the procedure | Drug | Ketamine group |
Primary outcome
Propofol consumption (milligrams)
Time frame: 24 hours after the endoscopy
Dose of prpofol (mg/kg) required for sedation during gastric balloon insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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 Fentanyl and Ketamine in people with Morbid Obesity, run by Mansoura 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 1 inclusion and 1 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 20 Nov 2018. 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?
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?
Propofol consumption (milligrams) (time frame: 24 hours after the endoscopy). 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 20 Nov 2018.