drugset / Trial / NCT07013955

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

NCT07013955

Phase 3 Enrolling by invitation 144 enrolled Minia University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2025-04-01
Primary completion
2025-11-01
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 0.5 % Intranasal
Comparator Dexmedetomidine Other / unclassified 1 ug/kg Intranasal
Comparator Midazolam Small molecule 0.2 mg/kg Intranasal

Indications

No indication recorded.