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

NCT ID: NCT04148599

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2020-06-13

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

Conditions

Inflammatory Response

Study Design

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

Study Groups

dexmedetomidine

dexmedetomidine ( precedex) infusion will be administered preoperatively and continued intraoperatively

Group Type: ACTIVE_COMPARATOR

dexmedetomidine infusion

Intervention Type: DRUG

a loading dose of 1µg/kg of dexmedetomidine (precedex) made to 50 ml using normal saline will be given over 10 minutes followed by infusion of dexmedetomidine with a dose of 0.5µg/kg/hour till the end of surgery.

lidocaine

Lidocaine (Xylocaine) infusion will be administered preoperatively and continued intraoperatively

Group Type: ACTIVE_COMPARATOR

lidocaine infusion

Intervention Type: DRUG

a loading dose of 1.5 mg/kg of lidocaine made to 50 ml using normal saline and given over 10 minutes followed by infusion of lidocaine with a dose of 1.5 mg/kg/hour till the end of surgery.

placebo

saline infusion will be administered preoperatively and continued intraoperatively

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

50 ml of normal saline given over 10 minutes followed by saline infusion intraoperatively at a rate of 10 ml/hour till the end of surgery.

Interventions

dexmedetomidine infusion

a loading dose of 1µg/kg of dexmedetomidine (precedex) made to 50 ml using normal saline will be given over 10 minutes followed by infusion of dexmedetomidine with a dose of 0.5µg/kg/hour till the end of surgery.

Intervention Type: DRUG

lidocaine infusion

a loading dose of 1.5 mg/kg of lidocaine made to 50 ml using normal saline and given over 10 minutes followed by infusion of lidocaine with a dose of 1.5 mg/kg/hour till the end of surgery.

Intervention Type: DRUG

Placebos

50 ml of normal saline given over 10 minutes followed by saline infusion intraoperatively at a rate of 10 ml/hour till the end of surgery.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abdelhamid, Bassant Mohamed, M.D.

INDIV

Sponsor Role: collaborator

Norma Osama Abdalla Zayed

OTHER

Sponsor Role: lead

Responsible Party

Norma Osama Abdalla Zayed

Assistant lecturer of anesthesia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emad Gerges, MD

Role: STUDY_DIRECTOR

National Cancer Institute (NCI)

Locations

National cancer institute

Cairo, , Egypt

Countries

Egypt

Other Identifiers

201617050.3

Identifier Type: -

Identifier Source: org_study_id