AminophyllineNCT05705050
Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy
A study testing Aminophylline group in people with Aminophylline and Pain, run by Tanta University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate the effect of intraoperative systemic aminophylline infusion on pain intensity in patients undergoing ureteroscopic lithotripsy surgeries with ureteric stent placement at the end of the procedure. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Aminophylline, Pain, Ureterocopic Lithotripsy
- What is being tested?
- Aminophylline group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to 19 Jun 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
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 to 50 years
- American society of anesthesiology (ASA) physical status I - II
- Body mass index (BMI) less than 30.0 kg/m2
- Scheduled for ureteroscopic lithotripsy surgery with D-J ureteric stent placement at the end of procedure
- Under general anesthesia.
Who cannot join
- Patients with central nervous system diseases, cardiovascular diseases, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
- Pregnancy or lactation.
- Patients with a history of allergy to aminophylline.
- Coffee consumption (more than 2 cups/day)
- Patients with opioid addiction or patients treated with B agonists, tranquilizers, or antidepressants.
- Short procedures less than 30 minutes or procedures not requiring D-J stent placement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy Surgeries
This study will be conducted to evaluate the effect of intraoperative systemic aminophylline infusion on pain intensity in patients undergoing ureteroscopic lithotripsy surgeries with ureteric stent placement at the end of the procedure.
- Conditions
- Aminophylline, Pain, Ureterocopic Lithotripsy
- Being tested
- Aminophylline group, Control group
- Keywords
- Aminophylline, Postoperative Pain, Ureterocopic Lithotripsy
- Medical subject headings
- Pain, Pain, Postoperative
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 100 ml normal saline over 20 minutes after induction of anesthesia and positioning of patients in lithotomy position.
Control groupOther
Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.
| Study group | Role | What they receive |
|---|---|---|
| Aminophylline group | Experimental | Patients will receive 4 mg/kg aminophylline diluted in 100 ml normal saline over 20 minutes after induction of anesthesia and positioning of patients in lithotomy position. Receives: Drug: Aminophylline group |
| Control group | Placebo comparator | Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
Visual analogue score (VAS) score: will be measured on arrival to PACU, at 30 minutes, 1 hour, 2 hour, 6, 12 and 24 hour after surgery.
Measured: In post anesthesia care unit (PACU)
Secondary outcomes (3)
Intensity of pain
Visual analogue score (VAS) score: will be measured on arrival to PACU, at 30 minutes, 1 hour, 2 hour, 6, 12 and 24 hour after surgery.
Measured: 24 hour after surgery
Total amount of opioid dose
If Patients reported VAS score more than 3, they will receive intravenous 0.5 mg /kg pethidine. All patients will be observed in PACU for at least 2 hour and in the ward on the day of surgery for confirming any side effects or complications.
Measured: 24 hour after surgery
The incidence of postoperative adverse reactions
the incidence of adverse reactions, such as arrhythmia, postoperative nausea and vomiting (PONV) and postoperative lightheadedness will be recorded in both groups.
Measured: 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start15 Feb 2023
- Primary completion18 Jun 2023
- Study completion19 Jun 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 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
- NCT05705050
- Sponsor's protocol ID
- 36264PR19/1/23
- Status last verified
- Jun 2023
- First submitted
- 21 Jan 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy Surgeries
- ClinicalTrials.gov ID
- NCT05705050
- Acronym / sponsor ID
- 36264PR19/1/23
- Conditions
- Aminophylline, Pain, Ureterocopic Lithotripsy
- Keywords
- Aminophylline, Postoperative Pain, Ureterocopic Lithotripsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 30 Jan 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 intraoperative systemic aminophylline infusion on pain intensity in patients undergoing ureteroscopic lithotripsy surgeries with ureteric stent placement at the end of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminophylline group | Experimental | Drug: Aminophylline groupPatients will receive 4 mg/kg aminophylline diluted in 100 ml normal saline over 20 minutes after induction of anesthesia and positioning of patients in lithotomy position. |
| Control group | Placebo comparator | Other: Control groupPatients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 18 to 50 years
- American society of anesthesiology (ASA) physical status I - II
- Body mass index (BMI) less than 30.0 kg/m2
- Scheduled for ureteroscopic lithotripsy surgery with D-J ureteric stent placement at the end of procedure
- Under general anesthesia.
Key exclusion criteria (6 listed)
- Patients with central nervous system diseases, cardiovascular diseases, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
- Pregnancy or lactation.
- Patients with a history of allergy to aminophylline.
- Coffee consumption (more than 2 cups/day)
- Patients with opioid addiction or patients treated with B agonists, tranquilizers, or antidepressants.
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 100 ml normal saline over 20 minutes after induction of anesthesia and positioning of patients in lithotomy position. | Drug | Aminophylline group |
| Control groupPatients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning. | Other | Control group |
Primary outcome
Intensity of pain
Time frame: In post anesthesia care unit (PACU)
Visual analogue score (VAS) score: will be measured on arrival to PACU, at 30 minutes, 1 hour, 2 hour, 6, 12 and 24 hour after surgery.
3 secondary outcomes
Intensity of pain
Time frame: 24 hour after surgery
Total amount of opioid dose
Time frame: 24 hour after surgery
The incidence of postoperative adverse reactions
Time frame: 24 hour after surgery
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 27 Jun 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author
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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 in people with Aminophylline and Pain, 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 5 inclusion and 6 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 27 Jun 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?
Intensity of pain (time frame: In post anesthesia care unit (PACU)). 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 27 Jun 2023.