Cancer LarynxNCT02739958
Effects of Propofol-dexmedetomidine on Immune Function in Patients With Cancer Larynx
A study testing Propofol group and Isoflurane group in people with Cancer Larynx and Total Laryngectomy, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this prospective, randomized clinical study is to compare between propofol and isoflurane on perioperative immune cell populations and function in patients undergoing total laryngectomy surgery. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cancer Larynx, Total Laryngectomy
- What is being tested?
- Propofol group and Isoflurane group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2016to 30 Oct 2016
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I- III
- Scheduled for total laryngectomy.
Who cannot join
- Patients refusal.
- Morbid obese patients (body mass index >40 kg/m2).
- Allergy to local anesthetics agents used.
- Severely altered consciousness level.
- Psychiatric disorders.
- Severe or uncompensated cardiovascular disease.
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- Severe renal disease.
- Severe hepatic disease.
- Severe endocrinal diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals, Ear Nose Thorat Department, Mansoura University
Al Mansurah, DK, 050
About this study
Official title: Effects of Propofol-dexmedetomidine on Immune Function During Total Laryngectomy Surgery Compared With Isoflurane Anesthesia
The aim of this prospective, randomized clinical study is to compare between propofol and isoflurane on perioperative immune cell populations and function in patients undergoing total laryngectomy surgery.
Read the detailed description
The perioperative period might be a critical time in primary cancer surgery because many factors can affect whether recurrence, or metastasis , or elimination by the immune system.
Cancer surgery can induce an acute inflammatory response, due to local tissue damage and the shedding of malignant cells into the blood and lymphocytic circulation although meticulous surgical manipulation. Many evidences suggest that several factors during the perioperative period can affect the immune system.
These could be attributed to the surgery per se, pain, anxiety, hypothermia, blood transfusion, anesthetic technique, and anesthetic drugs .Impairment in the immune system may allow malignant cells to escape immuno-surveillance and metastasize in the perioperative period.As well as increase the risk of postoperative complications, such as systemic inflammatory response syndrome, sepsis, and multi-organ failure.
Previous retrospective clinical studies of both breast and prostate cancer surgery have suggested an association between anaesthetic technique and cancer recurrence.
However ,other retrospective trials on various forms of cancer have shown no such benefit.
- Conditions
- Cancer Larynx, Total Laryngectomy
- Being tested
- Propofol group, Isoflurane group
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol groupDrug
Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.
Isoflurane groupDrug
Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | Patients receive only intravenous anesthetics Receives: Drug: Propofol group |
| Isoflurane group | Placebo comparator | Patients receive isoflurane /fentanyl anesthesia Receives: Drug: Isoflurane group |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD3 plasma level
Venous blood samples will be collected. The extracted venous blood samples will be mixed evenly in a special anti-coagulation test tube and stored in a refrigerator (at 4C).Flow cytometer will be used to detect the level of CD3+
Measured: for 7 days after procedure
Secondary outcomes (3)
Heart rate
Intraoperative heart rate changes
Measured: for 5 hours during the procedure
Blood pressure
Intraoperative blood pressure changes
Measured: for 5 hours during the procedure
Peripheral oxygen saturation measured with pulse oximetry
Intraoperative peripheral oxygen saturation changes as measured with pulse oximetry
Measured: for 5 hours during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start1 Mar 2016
- Primary completion30 Aug 2016
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer LarynxStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reem A El Sharkawy, MD, Principal investigator, Lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739958
- Sponsor's protocol ID
- R/16.01.112
- Status last verified
- Sep 2020
- First submitted
- 11 Mar 2016
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propofol-dexmedetomidine on Immune Function During Total Laryngectomy Surgery Compared With Isoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT02739958
- Acronym / sponsor ID
- R/16.01.112
- Conditions
- Cancer Larynx, Total Laryngectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 15 Apr 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 aim of this prospective, randomized clinical study is to compare between propofol and isoflurane on perioperative immune cell populations and function in patients undergoing total laryngectomy surgery.
Detailed description
The perioperative period might be a critical time in primary cancer surgery because many factors can affect whether recurrence, or metastasis , or elimination by the immune system.
Cancer surgery can induce an acute inflammatory response, due to local tissue damage and the shedding of malignant cells into the blood and lymphocytic circulation although meticulous surgical manipulation. Many evidences suggest that several factors during the perioperative period can affect the immune system.
These could be attributed to the surgery per se, pain, anxiety, hypothermia, blood transfusion, anesthetic technique, and anesthetic drugs .Impairment in the immune system may allow malignant cells to escape immuno-surveillance and metastasize in the perioperative period.As well as increase the risk of postoperative complications, such as systemic inflammatory response syndrome, sepsis, and multi-organ failure.
Previous retrospective clinical studies of both breast and prostate cancer surgery have suggested an association between anaesthetic technique and cancer recurrence.
However ,other retrospective trials on various forms of cancer have shown no such benefit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Active comparator | Drug: Propofol groupPatients receive only intravenous anesthetics |
| Isoflurane group | Placebo comparator | Drug: Isoflurane groupPatients receive isoflurane /fentanyl anesthesia |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I- III
- Scheduled for total laryngectomy.
Key exclusion criteria (9 listed)
- Patients refusal.
- Morbid obese patients (body mass index >40 kg/m2).
- Allergy to local anesthetics agents used.
- Severely altered consciousness level.
- Psychiatric disorders.
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 |
|---|---|---|
| Propofol groupAnesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h. | Drug | Propofol group |
| Isoflurane groupAnesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments | Drug | Isoflurane group |
Primary outcome
CD3 plasma level
Time frame: for 7 days after procedure
Venous blood samples will be collected. The extracted venous blood samples will be mixed evenly in a special anti-coagulation test tube and stored in a refrigerator (at 4C).Flow cytometer will be used to detect the level of CD3+
3 secondary outcomes
Heart rate
Time frame: for 5 hours during the procedure
Blood pressure
Time frame: for 5 hours during the procedure
Peripheral oxygen saturation measured with pulse oximetry
Time frame: for 5 hours during the 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 22 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Reem A El Sharkawy, MD principal investigator
Lecturer of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol group and Isoflurane group in people with Cancer Larynx and Total Laryngectomy, run by Mansoura 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 22 Sep 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.
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?
CD3 plasma level (time frame: for 7 days 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 22 Sep 2020.