Clinical trial NCT04148599: Effect of IV Infusion of Lidocaine Compared to IV Infusion of Dexmedetomidine on Proinflammatory Cytokines
Official title: Effect of Intravenous Infusion of Lidocaine in Comparison to Intravenous Infusion of Dexmedetomidine on Proinflammatory Cytokines and Stress Response in Pelviabdominal Cancer Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Response
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
Collaborators: name: Abdelhamid, Bassant Mohamed, M.D.
First posted: 2019-11-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to compare between intravenous infusion of dexmedetomidine and intravenous infusion of lidocaine in reduction of proinflammatory cytokines as IL-6 and TNF-α, some stress reactions (serum insulin and serum lactate),and postoperative analgesic requirements in patients undergoing surgery for pelviabdominal cancers.

Detailed description: Cancer patients who undergo surgery face many sources of stress. Surgery causes major cytokine and neuroendocrinal changes like increased levels of catecholamine and steroid hormones and other metabolic consequences .This stress response is considered a defense mechanism important for developing resistance to noxious insults.

The cytokine cascade caused by surgical stimulation is complex with various effects on the injured host. Increased production of proinflammatory cytokines from the site of injury causes many systemic changes such as metabolic derangements and hemodynamic instability. Some released cytokines like tumor necrosis factor alpha (TNF-α) and Interleukin 6(IL-6) can cause long lasting hyperalgesia. These proinflammatory cytokines change pain signal transmission through cytokine induced release of some neuroactive substances like nitric oxide, oxygen free radicals and excitatory amino acids. On the other hand anti-inflammatory cytokines are also released during inflammation to counteract these effects and keep balance.

Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that has sedative, analgesic, anesthetic-sparing properties with no respiratory depression. Its anti-inflammatory effects are being studied.

Intravenous lidocaine can be used in management of chronic pain. Lidocaine has anti-inflammatory properties and is capable of reducing postoperative analgesic requirements and the length of hospitalization.

The effect of both drugs on proinflammatory cytokines and stress response will be assessed

Eligibility criteria: Inclusion Criteria:

* American society of anesthesia (ASA) Physical Status classification:

ASA II physical status.

* Age between 18 to 60 years old.
* Patients who will undergo major pelviabdominal surgery.

Exclusion Criteria:

* Patient refusal.
* Allergy to local anesthetics.
* Cognitive disorders.
* uncontrolled diabetes or hypertension.

Primary outcomes:
measure: change in inflammatory mediators
timeFrame: preoperative (baseline), immediately postoperative and 24 hours postoperative
measure: change in serum level of insulin and lactate
timeFrame: preoperative (baseline), immediately postoperative and 24 hours postoperative
Secondary outcomes:
measure: Rescue analgesia
timeFrame: 1st 24 hours
measure: Visual analogue scale (VAS) score for pain
timeFrame: at 0 hour, 2 hour,6 hour, 12 hour and 24 hour
measure: postoperative morphine requirements
timeFrame: 1st 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National cancer institute
Study officials:
affiliation: National Cancer Institute (NCI)
name: Emad Gerges, MD
role: STUDY_DIRECTOR
References: