Trial record 2 of 27 for:    Open Studies | "Tongue Neoplasms"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Wuhan University
Sponsor:
Information provided by (Responsible Party):
tiejun Zhang, Wuhan University
ClinicalTrials.gov Identifier:
NCT01854021
First received: May 7, 2013
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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 Intervention
Tongue Cancer
Procedure: intravenous anesthesia
Procedure: combined intravenous-inhalational anesthesia
Procedure: inhalational anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer

Resource links provided by NLM:


Further study details as provided by Wuhan University:

Primary Outcome Measures:
  • Percentages of immune cells [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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:
  • Percentages of T lymphocytes subsets [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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

  • Percentages of Natural Killer cells [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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

  • Percentages of B lymphocytes [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854021

Contacts
Contact: tiejun zhang, M.D. 8602787686219 ztj@whu.edu.cn

Locations
China, Hubei
Hospital of stomatology of wuhan university Recruiting
Wuhan, Hubei, China, 430079
Contact: tiejun zhang, M.D.    8602787686219    ztj@whu.edu.cn   
Principal Investigator: tiejun zhang, M.D.         
Sponsors and Collaborators
tiejun Zhang
Investigators
Study Director: kebin Liu Master of Department of Anesthesiology of Hospital of Stomatology, Wuhan University
  More Information

No publications provided

Responsible Party: tiejun Zhang, Department of Anesthesiology , School and Hospital of Stomatology, Wuhan University, Wuhan University
ClinicalTrials.gov Identifier: NCT01854021     History of Changes
Other Study ID Numbers: wuhan university
Study First Received: May 7, 2013
Last Updated: May 16, 2013
Health Authority: China: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Wuhan University:
Anesthesia
general
Immunity
Tongue neoplasms
immune
general anesthesia

Additional relevant MeSH terms:
Tongue Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014