Clinical trial NCT07013955: Comparative Study Between the Effect of Dexmedetomidine ,Midazolam or Bupivacaine Packing During FESS on Surgical Field Visualization
Official title: Comparative Study Between the Effect of Nasal Packing With Dexmedetomidine, Midazolam or Bupivacaine on Surgical Field Visualization During Functional Endoscopic Sinus Surgery .
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Surgical Hemostasis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 144
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Intraoperative (for 2 hours maximally)
Secondary outcomes:
measure: Total requirement of nitroglycerine as a hypotensive agent.
timeFrame: postoperative (at the end of operation after 2 hours )
measure: Comparing the surgeon satisfaction among the study groups.
timeFrame: Postoperative (immediately at the end of the surgery )
measure: Hemodynamic changes among the study groups:
timeFrame: Intraoperative (baseline then every 5 minutes till the end of surgery )
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Minia University
name: Fatma R Mohammed, MD
role: PRINCIPAL_INVESTIGATOR
References: