Regional Block of the Nose for Hypotensive Anaesthesia in Septo-rhinoplasty

Study Overview
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Brief Summary
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Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces visibility in the operative field and hence satisfactory surgical outcome. The goal of our study to prove that regional block of the nose provides efficient hypotensive anesthesia

Official Title
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Efficacy of Regional Block of the Nose in Achieving Hypotensive Anaesthesia in Septo-rhinoplasty Surgery

Conditions
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Hypotensive Anesthesia

Intervention / Treatment
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* Other: General anesthesia with fentanyl boluses
* Procedure: Regional block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-II Scheduled for elective septo-rhinoplasty surgery Exclusion Criteria: Patients with hypertension or coronary artery disease, Patients with renal, hepatic or cerebral insufficiency, Patients with coagulopathy or receiving drugs influencing blood coagulation, Patients with known sensitivity to any of the study drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GS [General anesthesia]<br>Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1. | Other: General anesthesia with fentanyl boluses<br>* Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1<br>|
| Active Comparator: GR [General anesthesia + regional block]<br>Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1. Also patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. Fentanyl boluses of 0.5 mcg.Kg-1 will be given when needed to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1. | Other: General anesthesia with fentanyl boluses<br>* Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1<br>Procedure: Regional block<br>* Patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotensive anesthesia | Measurement of Mean arterial blood pressure | Intraoperative | 
| Requirements of Fentanyl | Assessment of intraoperative fentanyl doses of [Fentanyl boluses of 0.5 mcg.Kg-1 will be given to maintain mean arterial pressure (MAP) between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1] | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average category scale (ACS) | The surgeon will be asked, at the end of surgery, to assess bleeding in the surgical field using the average category scale 0-5 scale where [0=No bleeding and5=Severe bleeding] | Intraoperative |