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

Minia University

Status and phase: Invitation-only; Phase 3

Conditions: Surgical Hemostasis

Treatments: Drug: Dexmedetomidine; Drug: Bupivacaine; Drug: Saline; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT07013955

1465/02/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 4 patient groups, including a placebo group

Group I (Group C): (control group)

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline

Group II (Group D)

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Group III (Group M)

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam

Group IV (Group B)

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine