Surgical Hemostasis
Conditions
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.
Interventions
DRUGSaline
Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline.
DRUGDexmedetomidine
Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline.
DRUGMidazolam
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.
DRUGBupivacaine
Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking 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.
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed