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

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

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.

Study Overview

• Status: Completed
• Conditions: Total Laryngectomy; Cancer Larynx
• Intervention / Treatment: Drug: Propofol group; Drug: Isoflurane group

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University Hospitals, Ear Nose Thorat Department, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol group; Patients receive only intravenous anesthetics	Drug: Propofol group; Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.
Placebo Comparator: Isoflurane group; Patients receive isoflurane /fentanyl anesthesia	Drug: Isoflurane group; Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Reem A El Sharkawy, MD, Lecturer of Anesthesia and Surgical Intensive care

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): August 30, 2016
• Study Completion (Actual): October 30, 2016

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Isoflurane
• Other Study ID Numbers: R/16.01.112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED