The Effect of Preoperative Aminophylline

Phase 1

• Conditions: Recovery From Anesthesia
• Interventions: Drug: Aminophylline

• Registration Number: NCT04151381
• Lead Sponsor: Beni-Suef University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-08
• Study Start: 2019-11
• Study First Submitted QC: 2019-11-03
• Last Update Submitted: 2019-11-03
• Study First Posted: 2019-11-05
• Last Update Posted: 2019-11-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control group	Aminophylline	the control group (n =15 ) the patients will receive 20 ml of normal saline IV ,20 minutes before induction of general anesthesia .
Amiophylline (2mg)	Aminophylline	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
Aminophylline(4mg)	Aminophylline	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.

Primary Outcome Measures

Name	Time	Method
times to lose consciousness( LOC)	from the first second after administration of the anesthetic drugs and for 1-5 minutes	Times to lose of consciousness( LOC) which is defined as an OAA/S score 2 (loss of responsiveness to light tapping on shoulderor mild shaking with voice command to open eyes)

Trial Locations

Locations (2)

Beni-Suef University Hospital; 🇪🇬 Banī Suwayf, Egypt

Faculty of Medicine, Beni-SuefUniversity; 🇪🇬 Banī Suwayf, Egypt