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

Not Applicable

Recruiting

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

• Registration Number: NCT06848764
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study First Submitted: 2025-02-22
• Study First Submitted QC: 2025-02-22
• Study First Posted: 2025-02-27
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	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.
Dexmedetomidine group	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.

Primary Outcome Measures

Name	Time	Method
Surgical field	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 Outcome Measures

Name	Time	Method
Total morphine consumption	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.
Heart rate	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.
Incidence of adverse events	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.
Mean arterial pressure	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.
Degree of patient satisfaction	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).
Time to the first request for the rescue analgesia.	24 hours postoperatively	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).
Degree of pain	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.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt