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

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05738135
• Other study ID #: 36264PR58/1/23
• Status: Completed
• Phase: N/A
• Start date: February 25, 2023
• Est. completion date: August 25, 2023

Study information

• Verified date: March 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dexmedetomidine
• Functional Endoscopic Sinus Surgery

Intervention

Drug:
• Aminophylline group
Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.
• normal saline
Patients will receive 50 ml normal saline over 30 minutes.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Time to discharge from post anesthesia care unit	Time needed to achieve modified Aldrete Score =9 will be recorded.	Two hours after tracheal extubation.