Colon CancerPhase 1NCT05536362
Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery
A Phase 1 study testing TCI Propofol Injection in people with Colon Cancer and Post Operative Pain, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
The Study Showed that combining clonidine and ketamine together can increase the likelihood of achieving a sufficient level of anaesthesia while minimizing post-operative discomfort and inflammation. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Colon Cancer, Post Operative Pain
- What is being tested?
- TCI Propofol Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 28 Feb 2022
- Phase
- Phase 1
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I and II
- Patients with cancer colon
Who cannot join
- participants with a history of heart, renal and liver cell failure.
- allergic reaction to studied drugs, and history of epilepsy,
- hydrodynamic instability,
- chronic pain.
- mental illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consequences of Co-Administration of Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery
The Study Showed that combining clonidine and ketamine together can increase the likelihood of achieving a sufficient level of anaesthesia while minimizing post-operative discomfort and inflammation.
Read the detailed description
This study aimd to determine whether propofol infusion combined with clonidine and ketamine is more efficient in lowering the level of IL-8, preserving operation stability, and dropping post-operative pain and morphine intake.
When paralleled to propofol alone, TIVA employing propofol infusion along with pre-operation clonidine and ketamine is effective at preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake.
For this study, sixty contestants with ASA physical status I and II, ranging in age from 35 to 65, were scheduled for colon cancer operation lasting longer than 120 minutes. This study excluded participants with a history of heart, renal and liver cell failure, allergic reaction to studied drugs, and history of epilepsy, hemodynamic instability, chronic pain, or mental illness. Using a computer-generated randomization list, the patients were randomly allocated into two groups (30 patients each).
The treated group(Group T),which got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine, the control group(Group C),which received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%) .A third party was included in this study so neither the researchers nor the research subjects are aware of the intervention which the patients got.
- Conditions
- Colon Cancer, Post Operative Pain
- Being tested
- TCI Propofol Injection
- Medical subject headings
- Colonic Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCI Propofol InjectionDrug
Also called Ketamine and clonidine
To decrease postoperative pain after cancer colon surgery
| Study group | Role | What they receive |
|---|---|---|
| TCI propofol mixed with clonidine and ketamine | Experimental | Patient group,in which they got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine Receives: Drug: TCI Propofol Injection |
| TCI propofol mixed with a placebo | Experimental | Control group,in which they received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%) Receives: Drug: TCI Propofol Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Post-operative Pain
Assessment of the pain post-operatively in Pediatric patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain, measured in millimetres from the left end bar to the mark placed by the kid on the 10 cm line anchored by happy faces (no pain) to sad faces (severe pain).
Measured: 24-hour analgesic after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Feb 2021
- Primary completion1 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nirvana Elshalakany, Professor, Principal investigator, Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536362
- Sponsor's protocol ID
- Nirvana Ahmed
- Status last verified
- Oct 2022
- First submitted
- 7 Sep 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Co-Administration of Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery
- ClinicalTrials.gov ID
- NCT05536362
- Acronym / sponsor ID
- Nirvana Ahmed
- Conditions
- Colon Cancer, Post Operative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 10 Sep 2022 (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.
The Study Showed that combining clonidine and ketamine together can increase the likelihood of achieving a sufficient level of anaesthesia while minimizing post-operative discomfort and inflammation.
Detailed description
This study aimd to determine whether propofol infusion combined with clonidine and ketamine is more efficient in lowering the level of IL-8, preserving operation stability, and dropping post-operative pain and morphine intake.
When paralleled to propofol alone, TIVA employing propofol infusion along with pre-operation clonidine and ketamine is effective at preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake.
For this study, sixty contestants with ASA physical status I and II, ranging in age from 35 to 65, were scheduled for colon cancer operation lasting longer than 120 minutes. This study excluded participants with a history of heart, renal and liver cell failure, allergic reaction to studied drugs, and history of epilepsy, hemodynamic instability, chronic pain, or mental illness. Using a computer-generated randomization list, the patients were randomly allocated into two groups (30 patients each).
The treated group(Group T),which got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine, the control group(Group C),which received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%) .A third party was included in this study so neither the researchers nor the research subjects are aware of the intervention which the patients got.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake
| Arm | Type | Receives |
|---|---|---|
| TCI propofol mixed with clonidine and ketamine | Experimental | Drug: TCI Propofol InjectionPatient group,in which they got intravenous anaesthesia with TCI propofol mixed with clonidine and ketamine |
| TCI propofol mixed with a placebo | Experimental | Drug: TCI Propofol InjectionControl group,in which they received intravenous anaesthesia with TCI propofol mixed with a placebo (NaCl 0.9%) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I and II
- Patients with cancer colon
Key exclusion criteria (5 listed)
- participants with a history of heart, renal and liver cell failure.
- allergic reaction to studied drugs, and history of epilepsy,
- hydrodynamic instability,
- chronic pain.
- mental illness.
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 |
|---|---|---|
| TCI Propofol InjectionAlso: Ketamine and clonidineTo decrease postoperative pain after cancer colon surgery | Drug | TCI propofol mixed with a placebo, TCI propofol mixed with clonidine and ketamine |
Primary outcome
Measurement of Post-operative Pain
Time frame: 24-hour analgesic after surgery
Assessment of the pain post-operatively in Pediatric patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain, measured in millimetres from the left end bar to the mark placed by the kid on the 10 cm line anchored by happy faces (no pain) to sad faces (severe pain).
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 26 Oct 2022.
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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.
Nirvana Elshalakany, Professor principal investigator
Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TCI Propofol Injection in people with Colon Cancer and Post Operative Pain, run by Egymedicalpedia 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 5 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 26 Oct 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Measurement of Post-operative Pain (time frame: 24-hour analgesic after surgery). 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 26 Oct 2022.