By InvitationPhase 3

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

Egypt144 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range16 Years – 60 Years

SexALL

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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.

What they're measuring

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.

Timeframe: Intraoperative (for 2 hours maximally)

Trial details

NCT IDNCT07013955

SponsorMinia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-01

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