Effects of Propofol-dexmedetomidine on Immune Function in Patients With Cancer Larynx

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Propofol-dexmedetomidine on Immune Function During Total Laryngectomy Surgery Compared With Isoflurane Anesthesia

Conditions
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Cancer Larynx, Total Laryngectomy

Intervention / Treatment
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* Drug: Propofol group
* Drug: Isoflurane group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol group<br>Patients receive only intravenous anesthetics | Drug: Propofol group<br>* Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.<br>|
| Placebo Comparator: Isoflurane group<br>Patients receive isoflurane /fentanyl anesthesia | Drug: Isoflurane group<br>* Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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+ | for 7 days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Intraoperative heart rate changes | for 5 hours during the procedure | 
| Blood pressure | Intraoperative blood pressure changes | for 5 hours during the procedure | 
| Peripheral oxygen saturation measured with pulse oximetry | Intraoperative peripheral oxygen saturation changes as measured with pulse oximetry | for 5 hours during the procedure |