Recovery From AnesthesiaPhase 1NCT04151381
The Effect of Preoperative Aminophylline
A Phase 1 study testing Aminophylline in people with Recovery From Anesthesia, run by Beni-Suef University at 2 sites in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Recovery From Anesthesia
- What is being tested?
- Aminophylline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesEgypt
- Study dates
- Nov 2019to Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients age: 20-60 years
- Males and females patients
- American Society Of Anesthesiology (ASA) physical status I- II .
Who cannot join
- 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
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- Current treatment with B agonists, anticholinergic agents, tranquilizers, anticonvulsants ,or antidepressants.
- Pregnancy.
- Habitual coffee consumption exceeding 2 cups per day.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Medicine, Beni-SuefUniversity
Banī Suwayf, 6125
Samaa ak Rashwan, MD, 0201270159125, samkassemrashwan@gmail.com
- Recruiting
Beni-Suef University Hospital
Banī Suwayf, 6215
Samaa Rashwan, MD, 0201270159125
About this study
Official title: 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
Read the 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
- Being tested
- Aminophylline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminophyllineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 Receives: 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. Receives: Drug: Aminophylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from the first second after administration of the anesthetic drugs and for 1-5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recovery From AnesthesiaStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa Rashwan, Beni-Suef University
- Investigators
- Samaa ak Rashwan, MD, Principal investigator, Assisstant proffesor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151381
- Sponsor's protocol ID
- Beni-Suef Hospital, operation
- Status last verified
- Sep 2019
- First submitted
- 8 Sep 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33874898
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Aminophylline on the Recovery Profile After Major Pelvi-abdominal Surgeries: Randomized Controlled Double Blinded Study
- ClinicalTrials.gov ID
- NCT04151381
- Acronym / sponsor ID
- Beni-Suef Hospital, operation
- Conditions
- Recovery From Anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the control group | Placebo comparator | Drug: Aminophyllinethe control group (n =15 ) the patients will receive 20 ml of normal saline IV ,20 minutes before induction of general anesthesia . |
| Amiophylline (2mg) | Active comparator | Drug: AminophyllineAminophylline 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) | Active comparator | Drug: AminophyllineAminophylline 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients age: 20-60 years
- Males and females patients
- American Society Of Anesthesiology (ASA) physical status I- II .
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminophyllinethe 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. | Drug | Aminophylline(4mg), Amiophylline (2mg), the control group |
Primary outcome
times to lose consciousness( LOC)
Time frame: from the first second after administration of the anesthetic drugs and for 1-5 minutes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Derived from this study: PubMed 33874898Kasim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samaa ak Rashwan, MD principal investigator
Assisstant proffesor of anesthesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aminophylline in people with Recovery From Anesthesia, run by Beni-Suef University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samaa ak Rashwan, MD (020120159125, samakassemrashwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
times to lose consciousness( LOC) (time frame: from the first second after administration of the anesthetic drugs and for 1-5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.