Comparative Study Between the Effect of Dexmedetomidine ,Midazolam or Bupivacaine Packing During FESS on Surgical Field Visualization
NCT ID: NCT07013955
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
144 participants
INTERVENTIONAL
2025-04-01
2025-12-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
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 Groups
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Group I (Group C): (control group)
Patients in this group will receive only 5 ml of intranasal saline.
Saline
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.
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.
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.
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.
Group IV (Group B)
Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
Bupivacaine
Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
Interventions
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Saline
Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline.
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.
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.
Bupivacaine
Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
Eligibility Criteria
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Inclusion Criteria
* aged between 16 and 60 years old
* with BMI up to 30
* with ASA physical status I \& II.
Exclusion Criteria
* Pregnant and lactating females.
* Patients with severe liver, renal, or cardiac diseases
* Patients with repeated nasal surgeries.
* Patients with psychiatric conditions.
16 Years
60 Years
ALL
No
Sponsors
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Minia University
OTHER
Responsible Party
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Fatma Rabea Mohammed
Lecturer
Principal Investigators
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Fatma R Mohammed, MD
Role: PRINCIPAL_INVESTIGATOR
Minia University
Locations
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Faculty of Medicine
Minya, , Egypt
Countries
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Other Identifiers
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1465/02/2025
Identifier Type: -
Identifier Source: org_study_id
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