AnesthesiaNCT04376086
Segmental Epidural Block for Feeding Jeujunostomy in Cancer Patients
A study testing Epidural anesthesia and general anesthesia in people with Anesthesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aim is to compare the efficiency and safety of segmental epidural block versus general anesthesia in cancer patients undergoing surgical feeding jejunostomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Epidural anesthesia and general anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2019to 26 Apr 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for surgical feeding jejunostomy more than 18 years old
Who cannot join
- patien refusal Coagulation defect Abnormal kidney or liver functions Local infection at site of block Bone metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Segmental Epidural Block for Feeding Jejunostomy in Cancer Patients
This study aim is to compare the efficiency and safety of segmental epidural block versus general anesthesia in cancer patients undergoing surgical feeding jejunostomy
Read the detailed description
Comparing general anesthesia versus segmental epidural anesthesia in feeding jejunostomy
- Conditions
- Anesthesia
- Being tested
- Epidural anesthesia, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaProcedure or surgery
Segmental epidural analgesia
general anesthesiaProcedure or surgery
general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Active comparator | Patients will receive general anesthesia Receives: Procedure: general anesthesia |
| Epidural anesthesia | Experimental | Patients will receive epidural anesthesia Receives: Procedure: Epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic requirements
Analgesic requirments
Measured: first 24 hours
Haemodynamics
blood pressure
Measured: periooperative time
Secondary outcomes (1)
VAS score
visual analouge scale 0 minimum to 10 maximum score
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start10 Jun 2019
- Primary completion25 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376086
- Sponsor's protocol ID
- AP1904-50103
- Status last verified
- May 2021
- First submitted
- 10 Apr 2020
- Last updated
- 7 May 2021
- 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 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmental Epidural Block for Feeding Jejunostomy in Cancer Patients
- ClinicalTrials.gov ID
- NCT04376086
- Acronym / sponsor ID
- AP1904-50103
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 6 May 2020 (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 study aim is to compare the efficiency and safety of segmental epidural block versus general anesthesia in cancer patients undergoing surgical feeding jejunostomy
Detailed description
Comparing general anesthesia versus segmental epidural anesthesia in feeding jejunostomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Active comparator | Procedure: general anesthesiaPatients will receive general anesthesia |
| Epidural anesthesia | Experimental | Procedure: Epidural anesthesiaPatients will receive epidural anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for surgical feeding jejunostomy more than 18 years old
Key exclusion criteria (1 listed)
- patien refusal Coagulation defect Abnormal kidney or liver functions Local infection at site of block Bone metastases
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 |
|---|---|---|
| Epidural anesthesiaSegmental epidural analgesia | Procedure or surgery | Epidural anesthesia |
| general anesthesiageneral anesthesia | Procedure or surgery | General anesthesia |
Primary outcome
Analgesic requirements
Time frame: first 24 hours
Analgesic requirments
Haemodynamics
Time frame: periooperative time
blood pressure
1 secondary outcome
VAS score
Time frame: 24 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 7 May 2021.
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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.
Walaa Y Elsabeeny, MD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural anesthesia and general anesthesia in people with Anesthesia, run by National Cancer Institute, Egypt 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: finished, as of the sponsor's last update on 7 May 2021. 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?
Analgesic requirements (time frame: first 24 hours). 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 7 May 2021.