Clinical trial NCT04151381: The Effect of Preoperative Aminophylline
Official title: The Effect of Preoperative Aminophylline on the Recovery Profile After Major Pelvi-abdominal Surgeries: Randomized Controlled Double Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Recovery From Anesthesia
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: times to lose consciousness( LOC)
timeFrame: from the first second after administration of the anesthetic drugs and for 1-5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Faculty of Medicine, Beni-SuefUniversity
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University Hospital
Study officials:
affiliation: Assisstant proffesor of anesthesia
name: Samaa ak Rashwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasim SA, Bahr MH, Abdelkader M, Rashwan DAE. The effect of preoperative aminophylline on the recovery profile after major pelvic-abdominal surgeries: a randomized controlled double-blinded study. BMC Anesthesiol. 2021 Apr 19;21(1):122. doi: 10.1186/s12871-021-01340-7.