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Enrolling by invitation NCT07013955

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

Phase III Interventional Surgical Hemostasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saline, Dexmedetomidine, Midazolam, Bupivacaine.
Who it may be relevant to
Registry conditions: Surgical Hemostasis. Basic parameters: 16 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparative Study Between the Effect of Nasal Packing With Dexmedetomidine, Midazolam or Bupivacaine on Surgical Field Visualization During Functional Endoscopic Sinus Surgery .

Overview

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.

Detailed description

This study will be conducted in Minia University Hospital This prospective randomized double-blind controlled clinical study will be conducted on 144 adult patients of both sexes, aged between 16 and 60 years old, with BMI up to 30 with ASA physical status I \& II.

Parameters assessed:

* Intraoperative Monitoring:

1. Surgical field visualization using the Boezaart scale. 2. Hemodynamic changes among the study groups including the heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP), and oxygen saturation (SPO2) measured at baseline, (10 min after packing), every 5 mins till the end of the surgery. * Postoperative Evaluation

1. Assess postoperative pain using VAS every 1 hour for the 1st six hours, every 2 hours for 12 hours then every 4 hours till 24 hours postoperatively. 2. The sedation score will be assessed using the Ramsay sedation score as VAS intervals. 3. Surgeon satisfaction will be assessed by a Likert scale.

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.

Primary outcome measures

  • 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. [Time frame: Intraoperative (for 2 hours maximally)]
Secondary outcome measures (3)
  • Total requirement of nitroglycerine as a hypotensive agent. [Time frame: postoperative (at the end of operation after 2 hours )]
  • Comparing the surgeon satisfaction among the study groups. [Time frame: Postoperative (immediately at the end of the surgery )]
  • Hemodynamic changes among the study groups: [Time frame: Intraoperative (baseline then every 5 minutes till the end of surgery )]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine — Minya

Identifiers

NCT: NCT07013955 · 1465/02/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗