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

A Randomized Double-Blind Trial Comparing Lidocaine and Dexmedetomidine Infusions for Intraoperative Bleeding in Patients Undergoing Functional Endoscopic Sinus Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine; Intraoperative Bleeding; Functional Endoscopic Sinus Surgery; Lidocaine; Infusion
• Intervention / Treatment: Drug: Lidocaine; Drug: Dexmedetomidine

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Eldemerdash, MD; Phone Number: 00201114959206; Email: ahmedmonier@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • AIN shams university
    • Principal Investigator: Sarah A Afifi, MD
    • Principal Investigator: Sondos Afifi, MD
    • Contact: Ahmed M Eldemerdash; Phone Number: 00201114959206; Email: ahmedmonier@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine group; 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.	Drug: Lidocaine; 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.
Experimental: Dexmedetomidine group; 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.	Drug: Dexmedetomidine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical field	Surgical field will be assessed by Fromme et al. scale. (0-no bleeding, 1-slight bleeding, no suctioning of blood required, 2-slight bleeding occasional suctioning required, surgical field not threatened, 3-slight bleeding - frequent suctioning required. Bleeding threatens surgical field as few seconds after suction will be removed, 4-moderate bleeding - frequent suctioning required, bleeding threatens surgical field directly after suction will be removed, 5-severe bleeding - constant suctioning required, bleeding appeared faster than removed by suction. The surgical field severely threatened, and surgery not possible). The ideal category scale value will be determined to be ≤3.	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of patient satisfaction	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).	24 hours postoperatively
Total morphine consumption	Rescue analgesia of morphine will be given as 3 mg bolus if the VAS > 3 to be repeated after 30 min if pain persists until the Visual Analogue Scale (VAS)< 4. VAS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 12, 18, and 24h postoperatively.	24 hours postoperatively
Heart rate	Heart rate will be recorded before induction, every 5 minutes for the first 20 minutes, then every 15 minutes until the end of the surgery.	Till the end of surgery (Up to 4 hours)
Mean arterial pressure	Mean arterial pressure will be recorded before induction, every 5 minutes for the first 20 minutes, then every 15 minutes until the end of the surgery.	Till the end of surgery (Up to 4 hours)
Time to the first request for the rescue analgesia.	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).	24 hours postoperatively
Degree of pain	The degree of pain will be assessed using the Visual Analogue Scale (VAS). (VAS 0 represents "no pain," while 10 represents "the worst pain imaginable.") VAS will be assessed at the post-anesthesia care unit (PACU), 2, 4, 6, 12, 18, and 24h postoperatively.	24 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, upper airway obstruction, respiratory depression, emergence agitation, and postoperative awareness or any other complication will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 22, 2025
• First Submitted That Met QC Criteria: February 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Lidocaine; Dexmedetomidine
• Other Study ID Numbers: FMASU R42/2024/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No