Effect of Addition of Dexmedetomidine or Ketamine to Intravenous Infusion of Lidocaine on Proinflammatory Cytokines in Pelvi-abdominal Cancer Surgeries.

NCT06631625 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 0202037
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that effect of addition of dexmedetomidine or ketamine by IV infusion to lidocaine infusion may be more beneficial than lidocaine infusion alone on proinflammatory cytokines (IL-1, IL-6 and TNFα), and postoperative pain relief and decreased opioid consumption, reduced Length of stay.

Conditions

Pelvic Cancer; Abdominal Cancer; Surgery; Proinflammatory Cytokines

Outcome Measures

Primary Outcomes (1)

• Serum pro-inflammatory cytokines (IL-1, IL-6, TNFα).

  Preoperative, 2 hours after recovery and after 24 hours

Secondary Outcomes (12)

• • Pulse rate (Beats / min).

  Intraoperative

• Propofol consumption at induction (mg).

  Intraoperative

• Post-operative pain score.

  Visual analogue scale will be assessed every 2 hours postoperatively for 8 hours then at 12, 18 and 24 hours postoperatively.

• Time to first postoperative analgesic request (min).

  First 24 hours

• Perioperative analgesic consumptions.

  First 24 hours

Study Arms (3)

Group L receiving intravenous lidocaine infusion only

EXPERIMENTAL

Patients will receive 1.5mg /kg lidocaine 2%; intravenously as a bolus dose then 1.5mg/kg/hr lidocaine infusion using a 50cc syringe pump intra-operatively.

Drug: Lidocaine Intravenous Infusion

Group LK receiving lidocaine and ketamine infusion

EXPERIMENTAL

Patients will receive same infusion regimen of lidocaine 2%; as in group L plus 0.35 mg/kg ketamine intravenously as a bolus dose, followed by intravenous infusion of 0.2 mg/kg/h using a 50cc syringe pump intra- operatively.

Drug: Lidocaine and ketamine

Group LD receiving lidocaine and dexmedetomidine infusion

EXPERIMENTAL

Patients will receive same infusion regimen of lidocaine 2%; as in group L plus 0.5 μg/kg dexmedetomidine intravenously as a bolus dose, followed by intravenous infusion of 0.4 μg/kg/h using a 50cc syringe pump intra-operatively.

Drug: lidocaine and dexmedetomidine infusion

Interventions

Lidocaine Intravenous Infusion DRUG

Patients will receive 1.5mg /kg lidocaine 2%; intravenously as a bolus dose then 1.5mg/kg/hr lidocaine infusion using a 50cc syringe pump intra-operatively.

Group L receiving intravenous lidocaine infusion only

Lidocaine and ketamine DRUG

Patients will receive same infusion regimen of lidocaine 2%; as in group L plus 0.35 mg/kg ketamine intravenously as a bolus dose, followed by intravenous infusion of 0.2 mg/kg/h using a 50cc syringe pump intra- operatively.

Group LK receiving lidocaine and ketamine infusion

lidocaine and dexmedetomidine infusion DRUG

Patients will receive same infusion regimen of lidocaine 2%; as in group L plus 0.5 μg/kg dexmedetomidine intravenously as a bolus dose, followed by intravenous infusion of 0.4 μg/kg/h using a 50cc syringe pump intra-operatively.

Group LD receiving lidocaine and dexmedetomidine infusion

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-70 years.
• Female patients.
• ASA physical status class I or II.
• Elective resectable pelvi-abdominal cancer.

You may not qualify if:

• Patients with history of sensitivity to the studied drugs.
• Patients with cardiac conduction defects.
• Impaired kidney or liver function.
• Psychiatric disease or seizure disorder requiring medication within the previous 2 years.
• Opioid tolerant patient.
• Patient receiving nonsteroidal anti-inflammatory drugs within 1 week of surgery.
• Patient receiving B blockers, α2 ad-renergic agonist, sedatives, and antiarrythemic drugs.
• Cognitive dysfunction.
• Any history of antitumor treatments before surgery.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of medicine

Alexandria, Egypt

Location

Related Publications (1)

• Hassan MM, Saleh RG, Abdalla NO, Radwan NH, Abdelghfar EM. Effect of lidocaine infusion compared to dexmedetomidine infusion on proinflammatory cytokines and stress response in pelvi-abdominal cancer surgeries: a randomized clinical trial. Anaesth. pain intensive care 2021;26 (1):44-52. DOI: 10.35975/apic.v26i1.1765

  BACKGROUND

MeSH Terms

Conditions

Pelvic Neoplasms

Interventions

Lidocaine; Ketamine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: September 24, 2023
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months upto 1 year
• Access Criteria: Lidocaine, ketamine, dexmedetomidine, pelvi-abdominal cancer, proinflammatory cytokines

Locations

EG (1)