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

Sponsor
tiejun Zhang (Other)
Overall Status
Unknown status
CT.gov ID
NCT01854021
Collaborator
(none)
60
1
3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: intravenous anesthesia
  • Procedure: combined intravenous-inhalational anesthesia
  • Procedure: inhalational anesthesia
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: inhalational anesthesia

inhalational anesthesia

Procedure: inhalational anesthesia
inhalational anesthesia

Experimental: combined intravenous-inhalational anesthesia

combined intravenous-inhalational anesthesia

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

Experimental: intravenous anesthesia

intravenous anesthesia

Procedure: intravenous anesthesia
intravenous anesthesia

Outcome Measures

Primary Outcome Measures

  1. Percentages of immune cells [3 days]

    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

Secondary Outcome Measures

  1. Percentages of T lymphocytes subsets [3 days]

    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

  2. Percentages of Natural Killer cells [3 days]

    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. Percentages of B lymphocytes [3 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of stomatology of wuhan university Wuhan Hubei China 430079

Sponsors and Collaborators

  • tiejun Zhang

Investigators

  • Study Director: kebin Liu, Master of Department of Anesthesiology of Hospital of Stomatology, Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
tiejun Zhang, Department of Anesthesiology , School and Hospital of Stomatology, Wuhan University, Wuhan University
ClinicalTrials.gov Identifier:
NCT01854021
Other Study ID Numbers:
  • wuhan university
First Posted:
May 15, 2013
Last Update Posted:
May 17, 2013
Last Verified:
May 1, 2013
Keywords provided by tiejun Zhang, Department of Anesthesiology , School and Hospital of Stomatology, Wuhan University, Wuhan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2013