Effects of Propofol-dexmedetomidine on Immune Function in Patients With Cancer Larynx
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2016
CompletedSeptember 22, 2020
September 1, 2020
6 months
March 11, 2016
September 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Heart rate
for 5 hours during the procedure
Blood pressure
for 5 hours during the procedure
Peripheral oxygen saturation measured with pulse oximetry
for 5 hours during the procedure
Study Arms (2)
Propofol group
ACTIVE COMPARATORPatients receive only intravenous anesthetics
Isoflurane group
PLACEBO COMPARATORPatients receive isoflurane /fentanyl anesthesia
Interventions
Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.
Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical status I- III
- Scheduled for total laryngectomy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University Hospitals, Ear Nose Thorat Department, Mansoura University
Al Mansurah, DK, 050, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reem A El Sharkawy, MD
Lecturer of Anesthesia and Surgical Intensive Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2016
First Posted
April 15, 2016
Study Start
March 1, 2016
Primary Completion
August 30, 2016
Study Completion
October 30, 2016
Last Updated
September 22, 2020
Record last verified: 2020-09