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

NCT04148599 | Completed Phase 3

• 1 other identifier: 201617050.3
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Response

Outcome Measures

Primary Outcomes (2)

• change in inflammatory mediators

  change in plasma levels of IL-6 (pg/ml), TNF-α (pg/ml)

  preoperative (baseline), immediately postoperative and 24 hours postoperative

• 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 Outcomes (3)

• Rescue analgesia

  1st 24 hours

• Visual analogue scale (VAS) score for pain

  at 0 hour, 2 hour,6 hour, 12 hour and 24 hour

• postoperative morphine requirements

  1st 24 hours

Study Arms (3)

dexmedetomidine

ACTIVE COMPARATOR

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

Drug: dexmedetomidine infusion

lidocaine

ACTIVE COMPARATOR

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

Drug: lidocaine infusion

placebo

PLACEBO COMPARATOR

saline infusion will be administered preoperatively and continued intraoperatively

Drug: Placebos

Interventions

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.

dexmedetomidine

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.

lidocaine

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.

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patient refusal.
• Allergy to local anesthetics.
• Cognitive disorders.
• uncontrolled diabetes or hypertension.

Sponsors & Collaborators

• Norma Osama Abdalla Zayed: lead
• Abdelhamid, Bassant Mohamed, M.D.: collaborator

Study Sites (1)

National cancer institute

Cairo, 11769, Egypt

Location

Study Officials

• Emad Gerges, MD

  National Cancer Institute (NCI)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of anesthesia

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: November 1, 2019
• Study Start: January 2, 2018
• Primary Completion: June 10, 2020
• Study Completion: June 13, 2020
• Last Updated: August 3, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)