Clinical trial NCT02739958: Effects of Propofol-dexmedetomidine on Immune Function in Patients With Cancer Larynx
Official title: Effects of Propofol-dexmedetomidine on Immune Function During Total Laryngectomy Surgery Compared With Isoflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Larynx
Total Laryngectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this prospective, randomized clinical study is to compare between propofol and isoflurane on perioperative immune cell populations and function in patients undergoing total laryngectomy surgery.

Detailed description: The perioperative period might be a critical time in primary cancer surgery because many factors can affect whether recurrence, or metastasis , or elimination by the immune system.

Cancer surgery can induce an acute inflammatory response, due to local tissue damage and the shedding of malignant cells into the blood and lymphocytic circulation although meticulous surgical manipulation. Many evidences suggest that several factors during the perioperative period can affect the immune system.

These could be attributed to the surgery per se, pain, anxiety, hypothermia, blood transfusion, anesthetic technique, and anesthetic drugs .Impairment in the immune system may allow malignant cells to escape immuno-surveillance and metastasize in the perioperative period.As well as increase the risk of postoperative complications, such as systemic inflammatory response syndrome, sepsis, and multi-organ failure.

Previous retrospective clinical studies of both breast and prostate cancer surgery have suggested an association between anaesthetic technique and cancer recurrence.

However ,other retrospective trials on various forms of cancer have shown no such benefit.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I- III
* Scheduled for total laryngectomy.

Exclusion Criteria:

* Patients refusal.
* Morbid obese patients (body mass index \>40 kg/m2).
* Allergy to local anesthetics agents used.
* Severely altered consciousness level.
* Psychiatric disorders.
* Severe or uncompensated cardiovascular disease.
* Severe renal disease.
* Severe hepatic disease.
* Severe endocrinal diseases.

Primary outcomes:
measure: CD3 plasma level
timeFrame: for 7 days after procedure
Secondary outcomes:
measure: Heart rate
timeFrame: for 5 hours during the procedure
measure: Blood pressure
timeFrame: for 5 hours during the procedure
measure: Peripheral oxygen saturation measured with pulse oximetry
timeFrame: for 5 hours during the procedure
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals, Ear Nose Thorat Department, Mansoura University
state: DK
Study officials:
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
name: Reem A El Sharkawy, MD
role: PRINCIPAL_INVESTIGATOR
References: