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

NCT07013955 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 1 other identifier: 1465/02/2025
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Intraoperative (for 2 hours maximally)

Secondary Outcomes (3)

• Total requirement of nitroglycerine as a hypotensive agent.

  postoperative (at the end of operation after 2 hours )

• Comparing the surgeon satisfaction among the study groups.

  Postoperative (immediately at the end of the surgery )

• Hemodynamic changes among the study groups:

  Intraoperative (baseline then every 5 minutes till the end of surgery )

Study Arms (4)

Group I (Group C): (control group)

PLACEBO COMPARATOR

Patients in this group will receive only 5 ml of intranasal saline.

Drug: Saline

Group II (Group D)

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Group III (Group M)

ACTIVE COMPARATOR

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

Drug: Midazolam

Group IV (Group B)

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Interventions

Saline DRUG

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

Group I (Group C): (control group)

Dexmedetomidine DRUG

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 II (Group D)

Midazolam DRUG

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 III (Group M)

Bupivacaine DRUG

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

Group IV (Group B)

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• both sexes
• aged between 16 and 60 years old
• with BMI up to 30
• with ASA physical status I \& II.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of Medicine

Minya, 61511, Egypt

Location

MeSH Terms

Interventions

Sodium Chloride; Dexmedetomidine; Midazolam; Bupivacaine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Fatma R Mohammed, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 10, 2025
• Study Start: April 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)