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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01854021
Other study ID # wuhan university
Secondary ID
Status Recruiting
Phase N/A
First received May 7, 2013
Last updated May 16, 2013
Start date May 2013

Study information

Verified date May 2013
Source Wuhan University
Contact tiejun zhang, M.D.
Phone 8602787686219
Email ztj@whu.edu.cn
Is FDA regulated No
Health authority China: Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Procedure:
intravenous anesthesia
intravenous anesthesia
combined intravenous-inhalational anesthesia
combined intravenous-inhalational anesthesia
inhalational anesthesia
inhalational anesthesia

Locations

Country Name City State
China Hospital of stomatology of wuhan university Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
tiejun Zhang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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