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

Not Applicable

Completed

• Conditions: Aminophylline; Functional Endoscopic Sinus Surgery; Dexmedetomidine
• Interventions: Drug: Aminophylline group; Drug: normal saline

• Registration Number: NCT05738135
• Lead Sponsor: Tanta University

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

Study Timeline

• Study First Submitted: 2023-02-11
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-21
• Study Start: 2023-02-25
• Status Verified: 2023-03
• Primary Completion: 2023-08-25
• Study Completion: 2023-08-25
• Last Update Submitted: 2023-08-26
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aminophylline group	Aminophylline group	Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.
Control group	normal saline	Patients will receive 50 ml normal saline over 30 minutes.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Time to discharge from post anesthesia care unit	Two hours after tracheal extubation.	Time needed to achieve modified Aldrete Score ≥9 will be recorded.
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.
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.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, ElGharbiaa, Egypt