Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 7, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedMay 17, 2013
May 1, 2013
3 months
May 7, 2013
May 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Percentages of T lymphocytes subsets
3 days
Percentages of Natural Killer cells
3 days
Percentages of B lymphocytes
3 days
Study Arms (3)
inhalational anesthesia
EXPERIMENTALinhalational anesthesia
combined intravenous-inhalational anesthesia
EXPERIMENTALcombined intravenous-inhalational anesthesia
intravenous anesthesia
EXPERIMENTALintravenous anesthesia
Interventions
combined intravenous-inhalational anesthesia
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- tiejun Zhanglead
Study Sites (1)
Hospital of stomatology of wuhan university
Wuhan, Hubei, 430079, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
kebin Liu
Master of Department of Anesthesiology of Hospital of Stomatology, Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Department of Anesthesiology , School and Hospital of Stomatology, Wuhan University
Study Record Dates
First Submitted
May 7, 2013
First Posted
May 15, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2013
Last Updated
May 17, 2013
Record last verified: 2013-05