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

Inflammatory Response Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148599
• Other study ID #: 201617050.3
• Status: Completed
• Phase: Phase 3
• Start date: January 2, 2018
• Est. completion date: June 13, 2020

Study information

• Verified date: October 2019
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 13, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Response

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	National cancer institute	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Norma Osama Abdalla Zayed	Abdelhamid, Bassant Mohamed, M.D.

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in inflammatory mediators	change in plasma levels of IL-6 (pg/ml), TNF-a (pg/ml)	preoperative (baseline), immediately postoperative and 24 hours postoperative
Primary	change in serum level of insulin and lactate	change in serum levels of insulin (ng/ml) and lactate (ng/ml)	preoperative (baseline), immediately postoperative and 24 hours postoperative
Secondary	Rescue analgesia	time of first rescue analgesia	1st 24 hours
Secondary	Visual analogue scale (VAS) score for pain	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	at 0 hour, 2 hour,6 hour, 12 hour and 24 hour
Secondary	postoperative morphine requirements	total morphine consumption (mg)	1st 24 hours