Lidocaine and Dexmedetomidine Infusions for Intraoperative Bleeding in Functional Endoscopic Sinus Surgery

Ain Shams University

Status: Enrolling

Conditions: Dexmedetomidine; Infusion; Lidocaine; Functional Endoscopic Sinus Surgery; Intraoperative Bleeding

Treatments: Drug: Lidocaine; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06848764

FMASU R42/2024/2025

Details and patient eligibility

About

This work aims to compare lidocaine and dexmedetomidine infusions for intraoperative bleeding in patients undergoing functional endoscopic sinus surgery.

Full description

Sinus surgery is one of the most prevalent surgeries on the ear, nose, and throat (ENT). It is mainly carried out through endoscopy and significantly improves the clinical symptoms of patients with rhinosinusitis. Safe conditions must be maintained for this surgery, and the major problem reported during functional endoscopic sinus surgery (FESS) under general anesthesia (GA) is impaired visibility due to excessive bleeding.

Dexmedetomidine is an α2-adrenoceptor agonist with sedative, anxiolytic, sympatholytic, analgesic-sparing effects and minimal depression of respiratory function. It is potent and highly selective for α2-receptors.

Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life and a favorable safety profile and is,, therefore,, the LA of choice for continuous IV administration.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18 to 65 years old.
• American Society of Anesthesiologists (ASA) physical status I - II.
• Scheduled for elective functional endoscopic sinus surgery.

Exclusion criteria

• Diabetes mellitus.
• Coagulation disorders.
• Kidney and liver dysfunction.
• Cerebrovascular disease.
• Cardiovascular problems.
• High blood pressure.
• Asthma.
• Chronic obstructive pulmonary disease (COPD).
• End organ damage.
• Psychosis.
• Taking antipsychotic drugs.
• Allergy to study drugs.
• Substance abuse.
• Taking beta blockers.
• Heart rate of < 55 beat/minute.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Lidocaine group

Experimental group

Description:

Patients will receive lidocaine (1.5 mg/kg loading then 1mg/kg/h infusion) just after induction of anesthesia induction and continued until the end of the operation.

Treatment:

Drug: Lidocaine

Dexmedetomidine group

Experimental group

Description:

Patients will receive 1 μg/kg dexmedetomidine infusion over 10 min as a loading dose then 0.4-0.7 μg/kg/h just after induction of anesthesia induction and continued until the end of the operation.

Treatment:

Drug: Dexmedetomidine