The Effect of Preoperative Aminophylline

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

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

Study Overview

• Status: Unknown
• Conditions: Recovery From Anesthesia
• Intervention / Treatment: Drug: Aminophylline

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 6215
    • Recruiting
    • Beni-Suef University hospital
  • Banī Suwayf, Egypt, 6125
    • Recruiting
    • Faculty of Medicine, Beni-SuefUniversity
    • Contact: Samaa ak Rashwan, MD; Phone Number: 0201270159125; Email: samkassemrashwan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: the control group; the control group (n =15 ) the patients will receive 20 ml of normal saline IV ,20 minutes before induction of general anesthesia .	Drug: Aminophylline; 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.
ACTIVE_COMPARATOR: Amiophylline (2mg); 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	Drug: Aminophylline; 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.
ACTIVE_COMPARATOR: Aminophylline(4mg); 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.	Drug: Aminophylline; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
times to lose consciousness( LOC)	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)	from the first second after administration of the anesthetic drugs and for 1-5 minutes

Collaborators and Investigators

• Sponsor: Beni-Suef University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: September 8, 2019
• First Submitted That Met QC Criteria: November 3, 2019
• First Posted (ACTUAL): November 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Protective Agents; Cardiotonic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Aminophylline
• Other Study ID Numbers: Beni-Suef Hospital, operation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No