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The Effect of Preoperative Aminophylline

The Effect of Preoperative Aminophylline on the Recovery Profile After Major Pelvi-abdominal Surgeries: Randomized Controlled Double Blinded Study

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04151381
Enrollment
45
Registered
2019-11-05
Start date
2019-11-30
Completion date
2019-12-31
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recovery From Anesthesia

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.

Interventions

DRUGAminophylline

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

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
times to lose consciousness( LOC)from the first second after administration of the anesthetic drugs and for 1-5 minutesTimes 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)

Countries

Egypt

Contacts

Primary ContactSamaa ak Rashwan, MD
samakassemrashwan@gmail.com020120159125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026