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NCT Number: NCT07013955

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

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.

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Key information

Conditions

Surgical Hemostasis

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine

Minya, 61511, Egypt

About this study

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:
  • Surgical field visualization using the Boezaart scale.
  • 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
  • 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.
  • The sedation score will be assessed using the Ramsay sedation score as VAS intervals.
  • Surgeon satisfaction will be assessed by a Likert scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saline

Drug

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

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.

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.

Bupivacaine

Drug

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

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.

    Time frame: Intraoperative (for 2 hours maximally)

    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)

    • Slight bleeding, no suctioning required
    • Slight bleeding, occasional suctioning required
    • Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed
    • Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed
    • Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible

Secondary outcomes

  1. Total requirement of nitroglycerine as a hypotensive agent.

    Time frame: postoperative (at the end of operation after 2 hours )

    Intraoperative total requirement of nitroglycerine as a hypotensive agent.

  2. Comparing the surgeon satisfaction among the study groups.

    Time frame: Postoperative (immediately at the end of the surgery )

    Surgeon satisfaction will be assessed by a Likert scale Score 1 (very poor) Uncontrollable bleeding Score 2 (poor) Severe bleeding requiring repeated suctioning, with the quality of the field collapsing immediately after suctioning Score 3 (satisfactory) Moderate bleeding requiring intermittent suctioning. Score 4 (good) Partial bleeding, sometimes requiring suctioning the quality of the surgical field was good.

    Score 5 (excellent) No bleeding/bloodless field; the surgery field was excellent

  3. Hemodynamic changes among the study groups:

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

    2.Hemodynamic changes among the study groups including the heart rate (HR) in beat per minute, systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, mean blood pressure (MAP) in mmHg, and oxygen saturation (SPO2) in percentage measured at baseline, (10 min after packing), every 5 mins till the end of the surgery.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Acronym: FESS (Function

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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