Effects of Propofol-dexmedetomidine on Immune Function in Patients With Cancer Larynx

Mansoura University

Status: Completed

Conditions: Total Laryngectomy; Cancer Larynx

Treatments: Drug: Propofol group; Drug: Isoflurane group

Study type: Interventional

Funder types: Other

Identifiers

NCT02739958

R/16.01.112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Propofol group

Active Comparator group

Description:

Patients receive only intravenous anesthetics

Treatment:

Drug: Propofol group

Isoflurane group

Placebo Comparator group

Description:

Patients receive isoflurane /fentanyl anesthesia

Treatment:

Drug: Isoflurane group