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Effect of IV Infusion of Lidocaine Compared to IV Infusion of Dexmedetomidine on Proinflammatory Cytokines

N

Norma Osama Abdalla Zayed

Status and phase

Completed
Phase 3

Conditions

Inflammatory Response

Treatments

Drug: lidocaine infusion
Drug: Placebos
Drug: dexmedetomidine infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT04148599
201617050.3

Details and patient eligibility

About

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.

Full 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

Enrollment

54 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

54 participants in 3 patient groups, including a placebo group

dexmedetomidine
Active Comparator group
Description:
dexmedetomidine ( precedex) infusion will be administered preoperatively and continued intraoperatively
Treatment:
Drug: dexmedetomidine infusion
lidocaine
Active Comparator group
Description:
Lidocaine (Xylocaine) infusion will be administered preoperatively and continued intraoperatively
Treatment:
Drug: lidocaine infusion
placebo
Placebo Comparator group
Description:
saline infusion will be administered preoperatively and continued intraoperatively
Treatment:
Drug: Placebos

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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