The Effect of Preoperative Aminophylline

NCT04151381 | Unknown Phase 1

• 1 other identifier: Beni-Suef Hospital, operation
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

Conditions

Recovery From Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

the control group

PLACEBO COMPARATOR

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

Drug: Aminophylline

Amiophylline (2mg)

ACTIVE COMPARATOR

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

Aminophylline(4mg)

ACTIVE COMPARATOR

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

Interventions

Aminophylline 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); Amiophylline (2mg); the control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age: 20-60 years
• Males and females patients
• American Society Of Anesthesiology (ASA) physical status I- II .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (2)

Faculty of Medicine, Beni-SuefUniversity

Banī Suwayf, 6125, Egypt

RECRUITING

Beni-Suef University Hospital

Banī Suwayf, 6215, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 33874898 DERIVED

MeSH Terms

Interventions

Aminophylline

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Samaa ak Rashwan, MD

  Assisstant proffesor of anesthesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samaa ak Rashwan, MD

CONTACT

020120159125; samakassemrashwan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesiology

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: November 5, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)