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

Not Applicable

Completed

• Conditions: Cancer Larynx; Total Laryngectomy
• Interventions: Drug: Isoflurane group; Drug: Propofol group

• Registration Number: NCT02739958
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-15
• Primary Completion: 2016-08-30
• Study Completion: 2016-10-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-19
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isoflurane group	Isoflurane group	Patients receive isoflurane /fentanyl anesthesia
Propofol group	Propofol group	Patients receive only intravenous anesthetics

Primary Outcome Measures

Name	Time	Method
CD3 plasma level	for 7 days after procedure	Venous blood samples will be collected. The extracted venous blood samples will be mixed evenly in a special anti-coagulation test tube and stored in a refrigerator (at 4C).Flow cytometer will be used to detect the level of CD3+

Secondary Outcome Measures

Name	Time	Method
Heart rate	for 5 hours during the procedure	Intraoperative heart rate changes
Blood pressure	for 5 hours during the procedure	Intraoperative blood pressure changes
Peripheral oxygen saturation measured with pulse oximetry	for 5 hours during the procedure	Intraoperative peripheral oxygen saturation changes as measured with pulse oximetry

Trial Locations

Locations (1)

Mansoura University Hospitals, Ear Nose Thorat Department, Mansoura University; 🇪🇬 Mansoura, DK, Egypt