Intranasal Injection of Dexmedetomidine and Bupivacaine in Septoplasty Surgeries

Study Overview
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Brief Summary
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Pain is particularly common after nasal surgery, especially when bone manipulation and periosteal irritation are involved. Appropriate pain control is an important consideration in the post-surgical management of patients.

Detailed Description
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Multiple researches and clinical observations suggest that pain reduction can be achieved in nasal surgery by using local anesthesia.The combination of local anesthetic infiltration, directly in the surgical field, with general anesthesia provides beneficial analgesic effects by blocking nociceptive pathways, and there by it reduces the need for systemic analgesics. The use of α-2 Adrenergic receptor (adrenoceptor) agonists in anesthesia were the focus of interest for their sedative, analgesic, and perioperative sympatholytic and cardiovascular stabilizing effects with reduced anesthetic requirements. α-2 agonists, inhibit substance P release in the nociceptive pathway at the level of the dorsal root neuron; in addition, α-2 adrenergic receptors located at nerve endings may have a role in the analgesic effect of the drug by preventing norepinephrine release. In this study, the combined effects of dexmedetomidine with bupivacaine as local anesthetics vs bupivacaine, will be investigated in septoplasty to determine the need for rescue drugs as propanlol and nitroglycerine, as hypotensive agents,for bloodless surgical field and optimal procedure for pain control

Official Title
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Effects of Intranasal Injection of Dexmedetomidine Plus Bupivacaine on Anesthesia & Analgesia in Septoplasty Surgeries

Conditions
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Intranasal Dexmedetomidine, Intranasal Bupivacaine, Septoplasty Surgeries

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged from 18- 60 years ASA physical status I Undergoing septoplasty Exclusion Criteria: Patients with cardiovascular disease (congestive heart failure, coronary artery disease, hypertension. History of renal or hepatic insufficiency Endocrinal Diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group Bupivacaine<br>Group B; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) as preincisional local infiltration of the nasal mucosa of the nasal septum ,injected once before surgical intervention | Drug: Bupivacaine<br>* patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) preincisional local infiltration of the nasal mucosa.<br>* Other names: Marcaine;|
| Active Comparator: group Bupivacaine +Dexmedetomidine<br>group B+D; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa of the nasal septum,injected once before surgical intervention. | Drug: Dexmedetomidine<br>* Dexmedetomidine, a potent α-2 adrenoceptor agonist, is approximately 8 times more selective toward the α-2 adrenoceptors than clonidine. Patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa.<br>* Other names: Precedex,;Drug: Bupivacaine<br>* patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) preincisional local infiltration of the nasal mucosa.<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The precentage of patients that will take rescue drugs as nitroglycerin, propranolol. | the number of patients that will need rescue drugs: propranolol 1mg will be given then after 15 minutes (with no improvement of the surgical field) nitroglycerin (NTG) infusion will be added in a titrated manner 0.1-0.5 μg/kg/min gradually till the target MAP (±60 mmHg) is reached. | 3 hours |