Endometrial AdenocarcinomaPhase 4NCT03164590
Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines
A Phase 4 study testing Ketamine, dexmedetomidine and bupivacaine in people with Endometrial Adenocarcinoma, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Endometrial Adenocarcinoma
- What is being tested?
- Ketamine, dexmedetomidine and bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 Sep 2018
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II patients
- age range (18-60) years,
- weight (50- 90) kg
Who cannot join
- allergy to study drugs
- significant cardiac disease
- respiratory disease
- renal disease
- hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Inflammatory Cytokines Response After Total Abdominal Hysterectomy
This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total abdominal hysterectomy.
- Conditions
- Endometrial Adenocarcinoma
- Being tested
- Ketamine, dexmedetomidine, bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
patients receive local anesthetic wound infiltration with 1 mg /kg ketamine
dexmedetomidineDrug
patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine
bupivacaineDrug
patients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline
| Study group | Role | What they receive |
|---|---|---|
| ketamine | Active comparator | Not described Receives: Drug: Ketamine |
| dexmedetomidine | Active comparator | Not described Receives: Drug: dexmedetomidine |
| bupivacaine | Placebo comparator | Not described Receives: Drug: Ketamine; Drug: dexmedetomidine; Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of pain at rest and on coughing
severity of pain at rest and on coughing will be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 = worst imaginable pain)
Measured: 24 hours
Secondary outcomes (1)
sedation
sedation by using sedation 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 posted23 May 2017
- Study start1 Jun 2017
- Primary completion1 Aug 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial AdenocarcinomaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Adel El sherif,MD, Assiut University
- Investigators
- fatma el sherif, MD, Principal investigator, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164590
- Sponsor's protocol ID
- 388
- Status last verified
- Jan 2018
- First submitted
- 22 May 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Inflammatory Cytokines Response After Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT03164590
- Acronym / sponsor ID
- 388
- Conditions
- Endometrial Adenocarcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 23 May 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.
This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total abdominal hysterectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ketamine | Active comparator | Drug: Ketamine |
| dexmedetomidine | Active comparator | Drug: dexmedetomidine |
| bupivacaine | Placebo comparator | Drug: Ketamine, Drug: dexmedetomidine, Drug: bupivacaine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-II patients
- age range (18-60) years,
- weight (50- 90) kg
Key exclusion criteria (5 listed)
- allergy to study drugs
- significant cardiac disease
- respiratory disease
- renal disease
- hepatic disease
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 |
|---|---|---|
| Ketaminepatients receive local anesthetic wound infiltration with 1 mg /kg ketamine | Drug | bupivacaine, ketamine |
| dexmedetomidinepatients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine | Drug | bupivacaine, dexmedetomidine |
| bupivacainepatients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline | Drug | bupivacaine |
Primary outcome
severity of pain at rest and on coughing
Time frame: 24 hours
severity of pain at rest and on coughing will be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 = worst imaginable pain)
1 secondary outcome
sedation
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 22 Jan 2020.
- Individual participant dataSharing planned: No
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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.
fatma el sherif, MD principal investigator
South Egypt Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine, dexmedetomidine and bupivacaine in people with Endometrial Adenocarcinoma, 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 3 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 22 Jan 2020. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
severity of pain at rest and on coughing (time frame: 24 hours). 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 22 Jan 2020.