PancreatitisPhase 2AssiutuNCT02618668
Haemodynamic Stability of Ketamine/Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography
A Phase 2 study testing Ketamine / Propofol Admixture and Propofol in people with Pancreatitis and Cholangitis, run by Assiut University at 1 site in Egypt.
Trial summary
The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic stability, recovery time ,patient \& doctor satisfaction scores during Endoscopic Retrograde Cholangiopancreatography. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pancreatitis, Cholangitis
- What is being tested?
- Ketamine / Propofol Admixture and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2015to Sep 2018
- Phase
- Phase 2
- 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
- American Society of Anesthesiologists ( I ,II )
Who cannot join
- Presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity.
- History of substance abuse or dependence.
- History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haemodynamic Stability of Ketamine / Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography
The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic stability, recovery time ,patient \& doctor satisfaction scores during Endoscopic Retrograde Cholangiopancreatography.
- Conditions
- Pancreatitis, Cholangitis
- Being tested
- Ketamine / Propofol Admixture, Propofol
- Medical subject headings
- Pancreatitis, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine / Propofol AdmixtureDrug
propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+4 ml saline in a 20-ml syringe which resulted in0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol
PropofolDrug
2 mg/kg I.V
| Study group | Role | What they receive |
|---|---|---|
| Ketamine / Propofol Admixture | Experimental | Ketamine / Propofol Admixture: I.V propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+ 4 ml saline in a 20-ml syringe which resulted in 0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol. Receives: Drug: Ketamine / Propofol Admixture |
| Propofol | Active comparator | I.V propofol 2 mg/kg Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography
Measured: every 5 minutes up to 30minutes
saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography
Measured: every 5 minutes up to 30 minutes
Heart rate( beat/minute) from baseline of patient
Measured: every 5 minutes up to 30 minutes
Recovery score of patient
Measured: up to 10 minutes after the end of procedure
Secondary outcomes (1)
patient and doctor satisfaction score
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, m mostfa youssef mekky, Assiut University
- Investigators
- Mohamed A Bakr, Prof., Study chair, Assiut UniversityNagwa m osman, Asst.prof., Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618668
- Sponsor's protocol ID
- Momen01098983009
- Acronym
- Assiutu
- Status last verified
- Sep 2019
- First submitted
- 16 Nov 2015
- Last updated
- 23 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic Stability of Ketamine / Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography
- ClinicalTrials.gov ID
- NCT02618668
- Acronym / sponsor ID
- Assiutu / Momen01098983009
- Conditions
- Pancreatitis, Cholangitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 1 Dec 2015 (estimated)
- 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 investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic stability, recovery time ,patient \& doctor satisfaction scores during Endoscopic Retrograde Cholangiopancreatography.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine / Propofol Admixture | Experimental | Drug: Ketamine / Propofol AdmixtureKetamine / Propofol Admixture: I.V propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+ 4 ml saline in a 20-ml syringe which resulted in 0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol. |
| Propofol | Active comparator | Drug: PropofolI.V propofol 2 mg/kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists ( I ,II )
Key exclusion criteria (4 listed)
- Presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity.
- History of substance abuse or dependence.
- History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs.
- Pregnancy.
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 |
|---|---|---|
| Ketamine / Propofol Admixturepropofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+4 ml saline in a 20-ml syringe which resulted in0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol | Drug | Ketamine / Propofol Admixture |
| Propofol2 mg/kg I.V | Drug | Propofol |
Primary outcome
mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography
Time frame: every 5 minutes up to 30minutes
saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography
Time frame: every 5 minutes up to 30 minutes
Heart rate( beat/minute) from baseline of patient
Time frame: every 5 minutes up to 30 minutes
Recovery score of patient
Time frame: up to 10 minutes after the end of procedure
1 secondary outcome
patient and doctor satisfaction score
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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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.
Mohamed A Bakr, Prof. study chair
Assiut University
Nagwa m osman, Asst.prof. study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine / Propofol Admixture and Propofol in people with Pancreatitis and Cholangitis, 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 1 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: stopped early, as of the sponsor's last update on 23 Sep 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography (time frame: every 5 minutes up to 30minutes). The study lists 4 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 23 Sep 2019.