The Effect of Preoperative Aminophylline

NCT ID: NCT04151381

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2019-12-31

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.

Conditions

Recovery From Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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 .

Group Type: PLACEBO_COMPARATOR

Aminophylline

Intervention Type: DRUG

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.

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

Group Type: ACTIVE_COMPARATOR

Aminophylline

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Aminophylline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Samaa Rashwan

Assistant professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samaa ak Rashwan, MD

Role: PRINCIPAL_INVESTIGATOR

Assisstant proffesor of anesthesia

Locations

Faculty of Medicine, Beni-SuefUniversity

Banī Suwayf, , Egypt

Site Status: RECRUITING

Beni-Suef University Hospital

Banī Suwayf, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Samaa ak Rashwan, MD

Role: CONTACT

samakassemrashwan@gmail.com

020120159125

Facility Contacts

Samaa ak Rashwan, MD

Role: primary

samkassemrashwan@gmail.com

0201270159125

Samaa Rashwan, MD

Role: primary

0201270159125

References

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.

Reference Type: DERIVED

PMID: 33874898 (View on PubMed)

Other Identifiers

Beni-Suef Hospital, operation

Identifier Type: -

Identifier Source: org_study_id