The Effect of Preoperative Aminophylline

Beni-Suef University

Status and phase: Unknown; Phase 1

Conditions: Recovery From Anesthesia

Treatments: Drug: Aminophylline

Study type: Interventional

Funder types: Other

Identifiers

NCT04151381

Beni-Suef Hospital, operation

Details and patient eligibility

About

Several clinical studies and case reports suggested that aminophylline antagonizes the effects of diazepam , barbiturates , sevoflurane ,morphineand propofol.However, the available results from uncontrolled clinical settings make it difficult to quantify the specific effects of aminophylline on hypnotics and anesthetics

Full description

Aminophylline, a theophylline derivative, exerts multiple pharmacological effects, either through phosphodiesterase inhibition (i.e., a potent bronchodilating action, which is often used for the treatment of bronchial asthma) or via adenosine receptor blockade .It is generally considered that the majority of actions ascribed to therapeutic doses of xanthines (caffeine and theophylline) are due to their action as adenosine receptor antagonists.

To the best of the investigator's knowledge this hypothesis was not reported in patients scheduled for major pelvi-abdominal surgeries under general anesthesia , and aminophylline was not given as premedication to test this hypothesis as it was previously administrated after the end of surgery ,also it was recommended by previous clinical studies to evaluate the effective dose of aminophylline that affect the extubation and recovery time.

Enrollment: 45 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients age: 20-60 years
• Males and females patients
• American Society Of Anesthesiology (ASA) physical status I- II .

Exclusion criteria

• Patient refusal to participate in this study
• Patient with known sensitivity to aminophylline
• Patients with history of cardiac failure
• Patients with renal or hepatic dysfunction and in chronic alcoholism since clearance of aminophylline is decreased.
• Patients with peptic ulcer, hyperthyroidism, glaucoma,as these conditions may be exacerbated.
• Patients with opioid addiction
• Current treatment with B agonists, anticholinergic agents, tranquilizers, anticonvulsants ,or antidepressants.
• Pregnancy.
• Habitual coffee consumption exceeding 2 cups per day.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

the control group

Placebo Comparator group

Description:

the control group (n =15 ) the patients will receive 20 ml of normal saline IV ,20 minutes before induction of general anesthesia .

Treatment:

Drug: Aminophylline

Amiophylline (2mg)

Active Comparator group

Description:

Aminophylline 2mg:(n = 15) the patients will receive 2 mg/kg intravenous (IV) aminophylline diluted in 20 ml normal saline 20 minutes before induction of general anesthesia

Treatment:

Drug: Aminophylline

Aminophylline(4mg)

Active Comparator group

Description:

Aminophylline 4mg: (n = 15) the patients will receive 4 mg/kg intravenous (IV) aminophylline diluted in 20 ml normal saline 20 minutes before induction of general anesthesia .The study drugs will be given by an anesthetist unaware of the study protocol.

Treatment:

Drug: Aminophylline