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NCT Number: NCT06848764

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

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

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Key information

Conditions

Lidocaine Blood Loss, Surgical Dexmedetomidine Functional Endoscopic Sinus Surgery Hemorrhage Infusion Intraoperative Bleeding Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Surgical field

    Time frame: Intraoperatively

    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.

Secondary outcomes

  1. Total morphine consumption

    Time frame: 24 hours postoperatively

    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.

  2. Heart rate

    Time frame: Till the end of surgery (Up to 4 hours)

    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.

  3. Mean arterial pressure

    Time frame: Till the end of surgery (Up to 4 hours)

    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.

  4. Time to the first request for the rescue analgesia.

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).

  5. Degree of pain

    Time frame: 24 hours postoperatively

    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.

  6. Degree of patient satisfaction

    Time frame: 24 hours postoperatively

    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).

  7. Incidence of adverse events

    Time frame: 24 hours postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 27, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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