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

Tanta University52 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Aminophylline Dexmedetomidine Functional Endoscopic Sinus Surgery

Interventions

Aminophylline groupDRUG

Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.

normal salineDRUG

Patients will receive 50 ml normal saline over 30 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University Hospitals

Tanta, ElGharbiaa, Egypt

Outcomes

Primary Outcomes

Time to extubation

Extubation time, defined as the interval between the discontinuation of anesthetics to safe tracheal extubation.

Time frame: Two hours after discontinuation of anesthetics

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 60 minutes after tracheal extubation

Time to discharge from post anesthesia care unit

Time needed to achieve modified Aldrete Score ≥9 will be recorded.

Time frame: Two hours after tracheal extubation.

Data from ClinicalTrials.gov

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