SedationNCT03235609
Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy
A study testing Fentanyl and Ketamine in people with Sedation, run by Assiut University.
Trial summary
comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Sedation
- What is being tested?
- Fentanyl and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 16 Aug 2017to 15 Aug 2018
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients undergoing diagnostic GIT endoscopy
- ASA I-II
Who cannot join
- Emergency endoscopy
- Respiratory infection and hyperactive airways
- History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs
- Morbid obesity, and neuropsychiatric disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Propofol-Ketamine vs. Propofol-Fentanyl for Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy
comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy.
Read the detailed description
It is a prospective double blinded controlled study that will be carried out on 60 pediatric patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:- Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.
- Conditions
- Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Fentanyl Citrate
fentanyl used with propofol for sedation
KetamineDrug
Also called katalar
ketamine used with propofol for sedation
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Active comparator | Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Receives: Drug: Fentanyl |
| Ketamine | Active comparator | Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of desaturation
when oxygen saturation below 90%
Measured: up to 2 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start16 Aug 2017 (estimated)
- Primary completion15 Jun 2018 (estimated)
- Study completion15 Aug 2018 (estimated)
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 SedationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed galal aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235609
- Sponsor's protocol ID
- 17100212
- Status last verified
- Aug 2017
- First submitted
- 27 Jul 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Michaud L; Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Sedation for diagnostic upper gastrointestinal endoscopy: a survey of the Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Endoscopy. 2005 Feb;37(2):167-70. doi: 10.1055/s-2004-826144.
PubMed 15692933
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol-Ketamine vs. Propofol-Fentanyl for Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT03235609
- Acronym / sponsor ID
- 17100212
- Conditions
- Sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 16 Aug 2017 (estimated)
- Primary completion
- 15 Jun 2018 (estimated)
- Study completion
- 15 Aug 2018 (estimated)
- First posted
- 1 Aug 2017 (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.
comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy.
Detailed description
It is a prospective double blinded controlled study that will be carried out on 60 pediatric patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:- Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Active comparator | Drug: FentanylGroup I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. |
| Ketamine | Active comparator | Drug: KetamineGroup II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients undergoing diagnostic GIT endoscopy
- ASA I-II
Key exclusion criteria (4 listed)
- Emergency endoscopy
- Respiratory infection and hyperactive airways
- History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs
- Morbid obesity, and neuropsychiatric disorders
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 |
|---|---|---|
| FentanylAlso: Fentanyl Citratefentanyl used with propofol for sedation | Drug | Fentanyl |
| KetamineAlso: katalarketamine used with propofol for sedation | Drug | Ketamine |
Primary outcome
incidence of desaturation
Time frame: up to 2 days after operation
when oxygen saturation below 90%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Background: PubMed 15692933Michaud L; Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Sedation for diagnostic upper gastrointestinal endoscopy: a survey of the Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Endoscopy. 2005 Feb;37(2):167-70. doi: 10.1055/s-2004-826144.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl and Ketamine in people with Sedation, run by Assiut University.
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 2 inclusion and 4 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 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mohamed Aly (00201062011126, galalm1967@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of desaturation (time frame: up to 2 days after operation). 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 NCT03235609, 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 3 Aug 2017.