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

NCT06848764 | Recruiting

• 1 other identifier: FMASU R42/2024/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Total morphine consumption

  24 hours postoperatively

• Heart rate

  Till the end of surgery (Up to 4 hours)

• Mean arterial pressure

  Till the end of surgery (Up to 4 hours)

• Time to the first request for the rescue analgesia.

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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

Dexmedetomidine group

EXPERIMENTAL

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

Interventions

Lidocaine 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.

Lidocaine group

Dexmedetomidine 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.

Dexmedetomidine group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Lidocaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Ahmed M Eldemerdash, MD

CONTACT

00201114959206; ahmedmonier@med.asu.edu.eg

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

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

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)