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NCT Number: NCT02739958

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

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospitals, Ear Nose Thorat Department, Mansoura University

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol group

Drug

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

Isoflurane group

Drug

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

Primary outcomes

  1. CD3 plasma level

    Time frame: 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 outcomes

  1. Heart rate

    Time frame: for 5 hours during the procedure

    Intraoperative heart rate changes

  2. Blood pressure

    Time frame: for 5 hours during the procedure

    Intraoperative blood pressure changes

  3. Peripheral oxygen saturation measured with pulse oximetry

    Time frame: for 5 hours during the procedure

    Intraoperative peripheral oxygen saturation changes as measured with pulse oximetry

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 15, 2016
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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