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

NCT ID: NCT02739958

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2016-10-30

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.

Conditions

Cancer Larynx; Total Laryngectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Propofol group

Patients receive only intravenous anesthetics

Group Type: ACTIVE_COMPARATOR

Propofol group

Intervention Type: DRUG

Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.

Isoflurane group

Patients receive isoflurane /fentanyl anesthesia

Group Type: PLACEBO_COMPARATOR

Isoflurane group

Intervention Type: DRUG

Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments

Interventions

Propofol group

Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.

Intervention Type: DRUG

Isoflurane group

Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reem A El Sharkawy, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Anesthesia and Surgical Intensive Care

Locations

Mansoura University Hospitals, Ear Nose Thorat Department, Mansoura University

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

R/16.01.112

Identifier Type: -

Identifier Source: org_study_id