Aminophylline, Dexmedetomidine, Functional Endoscopic Sinus Surgery
Conditions
Keywords
Aminophylline, Dexmedetomidine, Hemodynamics, Recovery, Functional Endoscopic Sinus Surgery
Brief summary
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
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
Interventions
Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.
DRUGnormal saline
Patients will receive 50 ml normal saline over 30 minutes.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
1. Patients with central nervous system diseases, cardiovascular diseases, hypertension, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction. 2. Pregnancy or lactation. 3. Patients with a history of allergy to aminophylline. 4. Patients with recurrent sinus surgery, hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to extubation | Two hours after discontinuation of anesthetics | Extubation time, defined as the interval between the discontinuation of anesthetics to safe tracheal extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative heart rate | Intraoperative period | 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 mean arterial blood pressure | Intraoperative period | 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. |
| Postoperative sedation score | 60 minutes after tracheal extubation | 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. |
| Time to discharge from post anesthesia care unit | Two hours after tracheal extubation. | Time needed to achieve modified Aldrete Score ≥9 will be recorded. |
Countries
Egypt
Outcome results
None listed