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

Phase 3

• Conditions: Surgical Hemostasis
• Interventions: Drug: Saline; Drug: Dexmedetomidine; Drug: Midazolam; Drug: Bupivacaine

• Registration Number: NCT07013955
• Lead Sponsor: Minia University

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.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-04-01
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (Group C): (control group)	Saline	Patients in this group will receive only 5 ml of intranasal saline.
Group II (Group D)	Dexmedetomidine	Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline.
Group III (Group M)	Midazolam	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)	Bupivacaine	Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.

Primary Outcome Measures

Name	Time	Method
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.	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); 1. Slight bleeding, no suctioning required; 2. Slight bleeding, occasional suctioning required; 3. Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed; 4. Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed; 5. Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible

Secondary Outcome Measures

Name	Time	Method
Total requirement of nitroglycerine as a hypotensive agent.	postoperative (at the end of operation after 2 hours )	Intraoperative total requirement of nitroglycerine as a hypotensive agent.
Comparing the surgeon satisfaction among the study groups.	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
Hemodynamic changes among the study groups:	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.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Minya, Egypt