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

NCT ID: NCT06848764

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Lidocaine Dexmedetomidine Infusion Intraoperative Bleeding Functional Endoscopic Sinus Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Monier Ahmed Youssef Eldemerdash

Lecturer of Anesthesia, Intensive care, and pain management Faculty of Medicine Ain Shams University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed M Eldemerdash, MD

Role: CONTACT

00201114959206

Facility Contacts

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Ahmed M Eldemerdash

Role: primary

00201114959206

Other Identifiers

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FMASU R42/2024/2025

Identifier Type: -

Identifier Source: org_study_id

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