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

Tongue Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01854021
• Other study ID #: wuhan university
• 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. 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

• Tongue Cancer
• Tongue Neoplasms

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