Effect of IV Infusion of Lidocaine Compared to IV Infusion of Dexmedetomidine on Proinflammatory Cytokines
Status:
Recruiting
Sponsors
National Cancer Institute, Egypt
Abstract:
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.
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
Last Verified:September/30/2019
First Submitted:September/23/2019
Estimated Enrollment Submitted:October/29/2019
First Posted:October/31/2019
Last Update Submitted:October/29/2019
Last Update Posted:October/31/2019
Actual Study Start Date:January/1/2018
Estimated Primary Completion Date:November/30/2019
Estimated Study Completion Date:December/31/2019
Condition or disease:Inflammatory Response
Intervention/treatment:
Drug: dexmedetomidine
Drug: lidocaine
Drug: placebo
Phase:Phase 3
Study design:
Study Type:Interventional
Allocation:Randomized
Primary Purpose:Prevention
Masking:Double (Participant, Care Provider)
Arm group:
ArmIntervention/treatment
Active Comparator: dexmedetomidine
dexmedetomidine ( precedex) infusion will be administered preoperatively and continued intraoperatively
Drug: dexmedetomidine
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.
Active Comparator: lidocaine
Lidocaine (Xylocaine) infusion will be administered preoperatively and continued intraoperatively
Drug: lidocaine
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 Comparator: placebo
saline infusion will be administered preoperatively and continued intraoperatively
Drug: placebo
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.
Eligibility Criteria:
Ages Eligible for Study:18 Years to 18 Years
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes
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.

Outcome:
Primary Outcome Measures
1. change in inflammatory mediators [preoperative (baseline), immediately postoperative and 24 hours postoperative]
change in plasma levels of IL-6 (pg/ml), TNF-α (pg/ml)
2. change in serum level of insulin and lactate [preoperative (baseline), immediately postoperative and 24 hours postoperative]
change in serum levels of insulin (ng/ml) and lactate (ng/ml)
Secondary Outcome Measures
1. Rescue analgesia [1st 24 hours]
time of first rescue analgesia
2. Visual analogue scale (VAS) score for pain [at 0 hour, 2 hour,6 hour, 12 hour and 24 hour]
assessment of postoperative pain using the visual analogue scale score. the scale is a straight horizontal line (100 mm). The ends are defined as the extreme limits of pain orientated from the left (no pain) to the right (worst pain).The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.higher VAS score means worse pain
3. postoperative morphine requirements [1st 24 hours]
total morphine consumption (mg)
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