Aminophylline on Recovery in Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia

Study Overview
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Brief Summary
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This study will be conducted to evaluate the effect of intravenous aminophylline on hemodynamics and recovery of patients receiving dexmedetomidine infusion during functional endoscopic sinus surgery.

Detailed Description
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Aminophylline is a nonselective adenosine receptor antagonist used for the treatment of asthma and chronic obstructive pulmonary disease. It has been used to antagonize the effects of anaesthetic and analgesic agents

Official Title
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Effect of Intravenous Aminophylline on Hemodynamics and Recovery of Patients Undergoing Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia: A Randomized Controlled Study

Conditions
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Aminophylline, Dexmedetomidine, Functional Endoscopic Sinus Surgery

Intervention / Treatment
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* Drug: Aminophylline group
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 to 50 years, have American society of anesthesiology (ASA) physical status I - II and scheduled for elective FESS under general anesthesia and receiving dexmedetomidine infusion for controlled hypotension during surgery. Exclusion Criteria: Patients with central nervous system diseases, cardiovascular diseases, hypertension, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction. Pregnancy or lactation. Patients with a history of allergy to aminophylline. Patients with recurrent sinus surgery, hypertension.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aminophylline group<br>Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes. | Drug: Aminophylline group<br>* Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.<br>|
| Placebo Comparator: Control group<br>Patients will receive 50 ml normal saline over 30 minutes. | Drug: normal saline<br>* Patients will receive 50 ml normal saline over 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to extubation | Extubation time, defined as the interval between the discontinuation of anesthetics to safe tracheal extubation. | Two hours after discontinuation of anesthetics | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative heart rate | Heart rate will be recorded preoperatively (baseline), after loading dose of dexmedetomidine, after intubation, every 5 minutes during the study drug infusion, then every 15 minutes until end of surgery. | Intraoperative period | 
| Intraoperative mean arterial blood pressure | Mean arterial blood pressure will be recorded preoperatively (baseline), after loading dose of dexmedetomidine, after intubation, every 5 minutes during the study drug infusion, then every 15 minutes until end of surgery. | Intraoperative period | 
| Postoperative sedation score | Postoperative sedation will be evaluated using the Ramsay sedation score as: 1 = anxious, agitated, or restless 2= cooperative, oriented, and tranquil 3= responsive to commands 4= a sleep, but with brisk response to light, glabella tap, or loud auditory stimulus 5= a sleep, sluggish response to glabella tap, or auditory stimulus 6= a sleep, no response 6 is the highest sedation level Sedation score: will be measured at 15, 30, and 60 minutes after tracheal extubation. | 60 minutes after tracheal extubation | 
| Time to discharge from post anesthesia care unit | Time needed to achieve modified Aldrete Score ≥9 will be recorded. | Two hours after tracheal extubation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aminophylline, Dexmedetomidine, Hemodynamics, Recovery, Functional Endoscopic Sinus Surgery