Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery

NCT06837519 | Recruiting

• 1 other identifier: FMASU R22/2025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare lidocaine and dexmedetomidine infusion and their combination on perioperative pain in patients undergoing video-assisted thoracoscopic surgery.

Conditions

Lidocaine; Dexmedetomidine; Infusion; Perioperative Pain; Video-Assisted Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS)\> 3 to be repeated after 30 min if pain persists until the VAS \< 4.

  24 hours postoperatively

Secondary Outcomes (5)

• Time of extubation

  24 hours postoperatively

• Time to the first request for the rescue analgesia

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

• Degree of patient satisfaction

  24 hours postoperatively

• Incidence of adverse events

  24 hours postoperatively

Study Arms (3)

Lidocaine group

EXPERIMENTAL

Patients will receive lidocaine 0.3 mg/kg over 10 min loading, 0.3 mg/kg/h infusion after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of dexmedetomidine

Drug: Lidocaine

Dexmedetomidine group

EXPERIMENTAL

Patients will receive dexmedetomidine 0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of lidocaine.

Drug: Dexmedetomidine

Lidocaine and Dexmedetomidine group

EXPERIMENTAL

Patients will receive lidocaine (0.3 mg/kg in 10 min loading, 0.3 mg/kg/h infusion) and dexmedetomidine infusions (0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h) till 10 min before the end of the operation.

Drug: Lidocaine and Dexmedetomidine

Interventions

Lidocaine DRUG

Patients will receive lidocaine 0.3 mg/kg over 10 min loading, 0.3 mg/kg/h infusion after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of dexmedetomidine.

Lidocaine group

Dexmedetomidine DRUG

Patients will receive dexmedetomidine 0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of lidocaine.

Dexmedetomidine group

Lidocaine and Dexmedetomidine DRUG

Patients will receive lidocaine (0.3 mg/kg in 10 min loading, 0.3 mg/kg/h infusion) and dexmedetomidine infusions (0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h) till 10 min before the end of the operation.

Lidocaine and Dexmedetomidine group

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status of I, II.
• Patients undergoing video-assisted thoracoscopic surgery (VATS) under general anesthesia.

You may not qualify if:

• Hypersensitivity to any of the used drugs.
• Coagulation disorder.
• Body mass index \>35 kg/m2.
• History of chronic pain requiring daily opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks, and drug/alcohol abuse.
• Contraindication to the use of local anesthetics.
• Cardiovascular disease.
• Severe respiratory, renal or hepatic impairment.
• Insulin-dependent diabetes mellitus.
• Central nervous system or psychiatric disease.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Lidocaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Sarah A Afifi, MD

CONTACT

0501035864; Sarah606060@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Intensive care, and pain management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: February 20, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)