The Effect of Preoperative Aminophylline

Recovery From Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04151381
• Other study ID #: Beni-Suef Hospital, operation
• Status: Recruiting
• Phase: Phase 1
• Start date: November 2019
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Beni-Suef University
• Contact: Samaa ak Rashwan, MD
• Phone: 020120159125
• Email: samakassemrashwan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recovery From Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Egypt	Beni-Suef University Hospital	Bani Suwayf
Egypt	Faculty of Medicine, Beni-SuefUniversity	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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