Sedation in ERCPPhase 2NCT02651792
Ketamine- Propofol Versus Pethidine- Propofol in ERCP
A Phase 2 study testing ketamine- propofol and pethidine- propofol in people with Sedation in ERCP, run by Assiut University at 1 site in Egypt.
Trial summary
The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedation in ERCP
- What is being tested?
- ketamine- propofol and pethidine- propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Apr 2016
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- both gender
- age between 18-70
Who cannot join
- pregnant patients.
- morbid obesity.
- chronic obstructive pulmonary disease.
- complicated airway.
- American society of anesthesia (ASA) physical classification IV-V.
- history of allergy or contraindications to the drugs used in the study
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- emergency need for ERCP.
- those whose informed consent could not be signed.
- those with possible complex ERCP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine-propofol Versus Pethidine-propofol for Sedating Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)
The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction.
Read the detailed description
The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to <90% , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation scores of all patients will be recorded perioperatively. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure.
- Conditions
- Sedation in ERCP
- Being tested
- ketamine- propofol, pethidine- propofol
- Keywords
- ketamine, propofol, pethidine, ERCP, endoscopist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine- propofolDrug
Also called N01AX03 - Propofol
1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.
pethidine- propofolDrug
Also called meperidine - Propofol
1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction
| Study group | Role | What they receive |
|---|---|---|
| ketamine- propofol | Active comparator | IV Ketamine 1mg/kg + Propofol 1.2 mg/kg will be given for sedation. Receives: Drug: ketamine- propofol |
| pethidine- propofol | Active comparator | 1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction Receives: Drug: pethidine- propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)
Measured: Immediately after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation in ERCPStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled salah mohamed, Assiut University
- Investigators
- Mostafa S Abbas, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651792
- Sponsor's protocol ID
- ketfol versus pethidine
- Status last verified
- Apr 2016
- First submitted
- 29 Nov 2015
- Last updated
- 29 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine-propofol Versus Pethidine-propofol for Sedating Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP)
- ClinicalTrials.gov ID
- NCT02651792
- Acronym / sponsor ID
- ketfol versus pethidine
- Conditions
- Sedation in ERCP
- Keywords
- ketamine, propofol, pethidine, ERCP, endoscopist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Jan 2016 (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 investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction.
Detailed description
The investigators aim to investigate the differences between ketamine propofol and pethidine propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to <90% , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation scores of all patients will be recorded perioperatively. The Aldrete score was used to measure recovery from anesthesia at 5 and 10 min after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine- propofol | Active comparator | Drug: ketamine- propofolIV Ketamine 1mg/kg + Propofol 1.2 mg/kg will be given for sedation. |
| pethidine- propofol | Active comparator | Drug: pethidine- propofol1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- both gender
- age between 18-70
Key exclusion criteria (9 listed)
- pregnant patients.
- morbid obesity.
- chronic obstructive pulmonary disease.
- complicated airway.
- American society of anesthesia (ASA) physical classification IV-V.
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- propofolAlso: N01AX03 - Propofol1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol. | Drug | ketamine- propofol |
| pethidine- propofolAlso: meperidine - Propofol1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction | Drug | pethidine- propofol |
Primary outcome
endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition)
Time frame: Immediately after procedure.
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 29 Apr 2016.
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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.
Mostafa S Abbas, MD study chair
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 and pethidine- propofol in people with Sedation in ERCP, 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 2 inclusion and 9 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 29 Apr 2016. 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 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?
endoscopist satisfaction using 5 step scale (5= optimal condition; 1= poor condition) (time frame: Immediately after procedure.). 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 29 Apr 2016.