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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.
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:
Postoperative Evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Group C): (control group) | Placebo Comparator | Patients in this group will receive only 5 ml of intranasal saline. |
|
| Group II (Group D) | Active Comparator | Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline. |
|
| Group III (Group M) | Active Comparator | 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) | Active Comparator | Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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)
| Intraoperative (for 2 hours maximally) |
| Measure | Description | Time Frame |
|---|---|---|
| Total requirement of nitroglycerine as a hypotensive agent. | Intraoperative total requirement of nitroglycerine as a hypotensive agent. | postoperative (at the end of operation after 2 hours ) |
| Comparing the surgeon satisfaction among the study groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fatma R Mohammed, MD | Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Minya | 61511 | Egypt |
Data is available with corresponding authors on reasonable request
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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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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.
| 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. |
|
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 |
| Postoperative (immediately at the end of the surgery ) |
| Hemodynamic changes among the study groups: | 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. | Intraoperative (baseline then every 5 minutes till the end of surgery ) |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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