AminophyllineNCT05738135
Aminophylline on Recovery in Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia
A study testing Aminophylline group and normal saline in people with Aminophylline and Dexmedetomidine, run by Tanta University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate the effect of intravenous aminophylline on hemodynamics and recovery of patients receiving dexmedetomidine infusion during functional endoscopic sinus surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Aminophylline, Dexmedetomidine, Functional Endoscopic Sinus Surgery
- What is being tested?
- Aminophylline group and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2023to 25 Aug 2023
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 to 50 years, have American society of anesthesiology (ASA) physical status I - II and scheduled for elective FESS under general anesthesia and receiving dexmedetomidine infusion for controlled hypotension during surgery.
Who cannot join
- Patients with central nervous system diseases, cardiovascular diseases, hypertension, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
- Pregnancy or lactation.
- Patients with a history of allergy to aminophylline.
- Patients with recurrent sinus surgery, hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Aminophylline on Hemodynamics and Recovery of Patients Undergoing Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia: A Randomized Controlled Study
This study will be conducted to evaluate the effect of intravenous aminophylline on hemodynamics and recovery of patients receiving dexmedetomidine infusion during functional endoscopic sinus surgery.
Read the detailed description
Aminophylline is a nonselective adenosine receptor antagonist used for the treatment of asthma and chronic obstructive pulmonary disease. It has been used to antagonize the effects of anaesthetic and analgesic agents
- Being tested
- Aminophylline group, normal saline
- Keywords
- Aminophylline, Dexmedetomidine, Hemodynamics, Recovery, Functional Endoscopic Sinus Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminophylline groupDrug
Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.
normal salineDrug
Patients will receive 50 ml normal saline over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Aminophylline group | Experimental | Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes. Receives: Drug: Aminophylline group |
| Control group | Placebo comparator | Patients will receive 50 ml normal saline over 30 minutes. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to extubation
Extubation time, defined as the interval between the discontinuation of anesthetics to safe tracheal extubation.
Measured: Two hours after discontinuation of anesthetics
Secondary outcomes (4)
Intraoperative heart rate
Heart rate will be recorded preoperatively (baseline), after loading dose of dexmedetomidine, after intubation, every 5 minutes during the study drug infusion, then every 15 minutes until end of surgery.
Measured: Intraoperative period
Intraoperative mean arterial blood pressure
Mean arterial blood pressure will be recorded preoperatively (baseline), after loading dose of dexmedetomidine, after intubation, every 5 minutes during the study drug infusion, then every 15 minutes until end of surgery.
Measured: Intraoperative period
Postoperative sedation score
Postoperative sedation will be evaluated using the Ramsay sedation score as:
1 = anxious, agitated, or restless 2= cooperative, oriented, and tranquil 3= responsive to commands 4= a sleep, but with brisk response to light, glabella tap, or loud auditory stimulus 5= a sleep, sluggish response to glabella tap, or auditory stimulus 6= a sleep, no response 6 is the highest sedation level Sedation score: will be measured at 15, 30, and 60 minutes after tracheal extubation.
Measured: 60 minutes after tracheal extubation
Time to discharge from post anesthesia care unit
Time needed to achieve modified Aldrete Score ≥9 will be recorded.
Measured: Two hours after tracheal extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start25 Feb 2023
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AminophyllineStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738135
- Sponsor's protocol ID
- 36264PR58/1/23
- Status last verified
- Mar 2023
- First submitted
- 11 Feb 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding after 6 mon from publication
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Aminophylline on Hemodynamics and Recovery of Patients Undergoing Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05738135
- Acronym / sponsor ID
- 36264PR58/1/23
- Keywords
- Aminophylline, Dexmedetomidine, Hemodynamics, Recovery, Functional Endoscopic Sinus Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 21 Feb 2023 (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.
This study will be conducted to evaluate the effect of intravenous aminophylline on hemodynamics and recovery of patients receiving dexmedetomidine infusion during functional endoscopic sinus surgery.
Detailed description
Aminophylline is a nonselective adenosine receptor antagonist used for the treatment of asthma and chronic obstructive pulmonary disease. It has been used to antagonize the effects of anaesthetic and analgesic agents
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminophylline group | Experimental | Drug: Aminophylline groupPatients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes. |
| Control group | Placebo comparator | Drug: normal salinePatients will receive 50 ml normal saline over 30 minutes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged between 18 to 50 years, have American society of anesthesiology (ASA) physical status I - II and scheduled for elective FESS under general anesthesia and receiving dexmedetomidine infusion for controlled hypotension during surgery.
Key exclusion criteria (4 listed)
- Patients with central nervous system diseases, cardiovascular diseases, hypertension, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
- Pregnancy or lactation.
- Patients with a history of allergy to aminophylline.
- Patients with recurrent sinus surgery, hypertension.
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 |
|---|---|---|
| Aminophylline groupPatients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes. | Drug | Aminophylline group |
| normal salinePatients will receive 50 ml normal saline over 30 minutes. | Drug | Control group |
Primary outcome
Time to extubation
Time frame: Two hours after discontinuation of anesthetics
Extubation time, defined as the interval between the discontinuation of anesthetics to safe tracheal extubation.
4 secondary outcomes
Intraoperative heart rate
Time frame: Intraoperative period
Intraoperative mean arterial blood pressure
Time frame: Intraoperative period
Postoperative sedation score
Time frame: 60 minutes after tracheal extubation
Time to discharge from post anesthesia care unit
Time frame: Two hours after tracheal extubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding after 6 mon from publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aminophylline group and normal saline in people with Aminophylline and Dexmedetomidine, run by Tanta University at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to extubation (time frame: Two hours after discontinuation of anesthetics). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2023.