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

NCT07013955 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-06-10

No results posted yet for this 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.

Conditions

  • Surgical Hemostasis

Interventions

DRUG

Saline

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

DRUG

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.

DRUG

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.

DRUG

Bupivacaine

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

Sponsors & Collaborators

  • Minia University

    lead OTHER

Principal Investigators

  • Fatma R Mohammed, MD · Minia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-11-01
Completion
2025-12-01
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07013955 on ClinicalTrials.gov