Cancer Larynx, Total Laryngectomy
Conditions
Brief 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.
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.
Interventions
DRUGPropofol group
Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.
DRUGIsoflurane group
Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists physical status I- III * Scheduled for total laryngectomy.
Exclusion criteria
* 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. * Severe renal disease. * Severe hepatic disease. * Severe endocrinal diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD3 plasma level | 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+ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | for 5 hours during the procedure | Intraoperative heart rate changes |
| Blood pressure | for 5 hours during the procedure | Intraoperative blood pressure changes |
| Peripheral oxygen saturation measured with pulse oximetry | for 5 hours during the procedure | Intraoperative peripheral oxygen saturation changes as measured with pulse oximetry |
Countries
Egypt
Outcome results
None listed