Regional Nasal Block and Dexmedetomidine in Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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The purpose is to compare the efficacy of combined regional nasal block and general anesthesia versus general anesthesia with dexmedetomidine during endoscopic sinus surgery in optimizing intraoperative surgical field.

Detailed Description
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This study will be done to compare between two different techniques including regional nasal block and dexmedetomidine in optimizing intraoperative surgical field according to average category scale

Official Title
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Comparison Between Combined Regional Nasal Block and General Anesthesia Versus General Anesthesia With Dexmedetomidine During Endoscopic Sinus Surgery

Conditions
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Drug Use

Intervention / Treatment
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* Drug: Bupivacaine HCl 0.5% Injectable Solution
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of ASA I or ASA II physical status. Patients with age 18-65 years. Exclusion Criteria: Patients with physical status ASA III, IV. Known allergic reactions to local anesthetics. Patients with history for cerebrovascular or coronary insufficiency. Patients with infection at the block site. Patients with coagulopathy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: regional nasal block<br>sphenopalatine ganglion block with general anesthesia | Drug: Bupivacaine HCl 0.5% Injectable Solution<br>* using nasal block including sphenopalatine ganglion block with general anesthesia to optimize surgical field<br>* Other names: Lidocaine 2%;|
| Active Comparator: dexmedetomidine<br>use the drug with general anesthesia | Drug: Dexmedetomidine<br>* using dexmedetomidine with induction of general anesthesia to optimize surgical field<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimizing intraoperative surgical field | Comparison between efficacy of the two techniques in optimizing intraoperative surgical field which will be measured using the average category scale(where grade 0 is defined as no bleeding and grade 5 is defined as severe bleeding, constant suctioning required). | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate in beat per minute | The heart rate will be measured in (beat/minute) at the commencement of surgery and at each assessment of the surgical field. The average mean values during the surgical procedures will be calculated in each group. | Up to 8 months | 
| Blood loss in millilitres | Blood loss will be measured in millilitres as that collected in the suction apparatus and by weight of the nasal swabs. | Up to 8 months | 
| endtidal sevoflurane concentration in MAC% | Endtidal sevoflurane concentration will be used as an indicator of inhaled anaesthetic dose. Mean end-tidal sevoflurane concentration will be calculated for each patient as the average of all concentrations recorded will be measured in MAC% | Up to 8 months | 
| phentolamine requirements in milligrams | The total dose of additional hypotensive agent (phentolamine) requirements will be measured in milligrams | Up to 8 months | 
| Duration of anesthesia in minutes | Duration of anesthesia will be measured in minutes | Up to 8 months | 
| Pain assessment with visual analogue scale(VAS) | Pain intensity will be measured with a 10-cm visual analogue scale (where 0 is defined as no pain at all and 10 as the worst possible pain) at 2, 6 and 12 hours postoperatively. | Up to 8 months | 
| Mean blood pressure in mmHg | The mean blood pressure will be measured in mmHg at the commencement of surgery and at each assessment of the surgical field. The average mean values during the surgical procedures will be calculated in each group. | Up to 8 months | 
| Duration of surgery in minutes | Duration of surgery will be measured in minutes | Up to 8 months |