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Clinical Trials in Egypt / NCT07013955
Enrolling by invitation Phase 3

Comparative Study Between the Effect of Dexmedetomidine ,Midazolam or Bupivacaine Packing During FESS on Surgical Field Visualization

NCT07013955 · tracked via the Priya Life Science Egypt tracker
Sponsor
Minia University
Phase
Phase 3
Started
2025-04-01
Last updated
2025-06-10

Condition(s) studied

Surgical Hemostasis

Investigational drug(s) / intervention(s)

SalineDexmedetomidine →Midazolam →Bupivacaine →

Saline: Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline.

Dexmedetomidine: Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline.

Midazolam: Group III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline.

Bupivacaine: Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.

Study summary

The goal of this interventional study is to compare the nasal packing with dexmedetomidine .midazolam or bupivacaine on surgical field visualization during FESS . Study groups :

Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline.

Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline.

Group III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline.

Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.

Eligibility

Sex
ALL
Min age
16 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * both sexes * aged between 16 and 60 years old * with BMI up to 30 * with ASA physical status I \& II. Exclusion Criteria: * Patients with a history of allergy to the study drugs. * Pregnant and lactating females. * Patients with severe liver, renal, or cardiac diseases * Patients with repeated nasal surgeries. * Patients with psychiatric conditions.

Primary outcome measure(s)

  • We aim to assess the efficacy of intranasal packing with dexmedetomidine, midazolam, or bupivacaine in reducing bleeding during FESS operations in patients who require general anesthesia with endotracheal intubation. — Intraoperative (for 2 hours maximally)
    Evaluate the efficacy of intranasal packing with dexmedetomidine, midazolam, or bupivacaine in improving surgical field visualization using the Boezaart Score. Grade Assessment 0 No bleeding (cadaveric conditions) 1. Slight bleeding, no suctioning required 2. Slight bleeding, occasional suctioning required 3. Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed 4. Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed 5. Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible

Trial sites (1)

FacilityCityRegionStatus
Faculty of Medicine Minya Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07013955 on ClinicalTrials.gov ↗ ← All trials in Egypt