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

Total Laryngectomy Clinical Trial

Official title:

Effects of Propofol-dexmedetomidine on Immune Function During Total Laryngectomy Surgery Compared With Isoflurane Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739958
• Other study ID #: R/16.01.112
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: October 30, 2016

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2016
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Larynx
• Total Laryngectomy

Intervention

Drug:
• Propofol group
Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.
• Isoflurane group
Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals, Ear Nose Thorat Department, Mansoura University	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD3 plasma level	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+	for 7 days after procedure
Secondary	Heart rate	Intraoperative heart rate changes	for 5 hours during the procedure
Secondary	Blood pressure	Intraoperative blood pressure changes	for 5 hours during the procedure
Secondary	Peripheral oxygen saturation measured with pulse oximetry	Intraoperative peripheral oxygen saturation changes as measured with pulse oximetry	for 5 hours during the procedure