Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer

Study Overview
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Brief Summary
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Surgical excision is the mainstay of treatment for tongue cancer. However, surgery-induced immunosuppression has been implicated in the development of post-operative septic complications and neoplasm metastasis. General anesthesia is considered to not only suppress surgical stress, but also affect the immune function directly，such as altering the number and activity of immune cells. It is reported that some anesthetics increase susceptibility to tumor metastasis, apparently by suppressing natural killer cell activity. Different anesthetic techniques and anesthetics used in anesthesia have shown different effects on immunity. Many of the studies were animal trials or performed in vitro; in addition, most are focused on a single drug. To date, there is little published prospective clinical research designed specifically to investigate the effects of different general anesthetic technique on immune function in patients with oral malignant tumors. The aim of this study is going to characterize the immune response of patients undergoing surgery for tongue cancer under 3 types of general anesthesia.

Official Title
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Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer

Conditions
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Tongue Cancer

Intervention / Treatment
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* Procedure: intravenous anesthesia
* Procedure: combined intravenous-inhalational anesthesia
* Procedure: inhalational anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients were scheduled for elective surgery for tongue cancer under general anesthesia. None of the patients had a history of endocrine, immune and circulatory system diseases; Exclusion criteria were also contraindications for receiving chemotherapy Exclusion Criteria: contraindications for receiving chemotherapy, receiving perioperative blood transfusion, or preoperative and perioperative treatment with hormones and immunomodulatory agent. Patients who suffered from any surgical complications such as infection were also excluded from our study. -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhalational anesthesia<br>inhalational anesthesia | Procedure: inhalational anesthesia<br>* inhalational anesthesia<br>|
| Experimental: combined intravenous-inhalational anesthesia<br>combined intravenous-inhalational anesthesia | Procedure: combined intravenous-inhalational anesthesia<br>* combined intravenous-inhalational anesthesia<br>|
| Experimental: intravenous anesthesia<br>intravenous anesthesia | Procedure: intravenous anesthesia<br>* intravenous anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of immune cells | 30 min before induction, 1 h, 3 h and 5 h after induction; at the end of operation and 24h, 48 h and 72 h after operation | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of T lymphocytes subsets | 30 min before induction, 1 h, 3 h and 5 h after induction; at the end of operation and 24h, 48 h and 72 h after operation | 3 days | 
| Percentages of Natural Killer cells | 30 min before induction, 1 h, 3 h and 5 h after induction; at the end of operation and 24h, 48 h and 72 h after operation | 3 days | 
| Percentages of B lymphocytes | 30 min before induction, 1 h, 3 h and 5 h after induction; at the end of operation and 24h, 48 h and 72 h after operation | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, general, Immunity, Tongue neoplasms, immune, general anesthesia