Skip to main content
OpenTrials
Completed

NCT Number: NCT04148599

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammatory Response

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National cancer institute

Cairo, 11769, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine infusion

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 infusion

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.

Placebos

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.

Primary outcomes

  1. change in inflammatory mediators

    Time frame: 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

    Time frame: preoperative (baseline), immediately postoperative and 24 hours postoperative

    change in serum levels of insulin (ng/ml) and lactate (ng/ml)

Secondary outcomes

  1. Rescue analgesia

    Time frame: 1st 24 hours

    time of first rescue analgesia

  2. Visual analogue scale (VAS) score for pain

    Time frame: 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

    Time frame: 1st 24 hours

    total morphine consumption (mg)

Sponsors and collaborators

Lead sponsor

Norma Osama Abdalla Zayed

Other

Collaborators

  • Abdelhamid, Bassant Mohamed, M.D.

Registry information

Official study title

Effect of Intravenous Infusion of Lidocaine in Comparison to Intravenous Infusion of Dexmedetomidine on Proinflammatory Cytokines and Stress Response in Pelviabdominal Cancer Surgeries

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2019
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.