Anesthesia; FunctionalNCT03438253
Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.
An observational study of Anesthesia; Functional, run by Aligarh Muslim University.
Trial summary
Penile engorgement during intraoperative period is of rare occurrence however when do happens, leads to difficulty in performing and even cancellation of elective urogenital surgery. The mechanism behind intraoperative penile engorgement is complex and involves various factors. Read more about this study
- Who is it for?
- Ages 2 to 12 years, men only
- Conditions the study is for
- Anesthesia; Functional
- What is being tested?
- spinal anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 386 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2017to 30 Jan 2018
- Phase
- Observational
- 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 2 to 12 years
- Men only
- Child
Study population: All ASA grade 1 \& 2 pediatric patients having age between 2 to 12 years.
Who may be able to join
- American Society of Anesthesiologist grade1 \& 2
- Elective urogenital surgery of expected duration less than one hour
Who cannot join
- patients with local infection, coagulation abnormalities, expected duration of surgery >1 hour and spinal anomalies.
- parents of patient not giving consent for spinal anaesthesia.
About this study
Official title: Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia: A Prospective Cohort Study to Discuss the Role of Anesthetic Technique and Other Common Contributing Factors.
Penile engorgement during intraoperative period is of rare occurrence however when do happens, leads to difficulty in performing and even cancellation of elective urogenital surgery. The mechanism behind intraoperative penile engorgement is complex and involves various factors. One common myth is that penile engorgement occurs only during spinal anaesthesia and not in general anaesthesia. In this study we intend to report the incidence and management of intraoperative penile engorgement in pediatric patients undergoing urogenital operations under spinal anesthesia with/without sedation over a period of one year. The pathophysiology and role of common contributing factors leading to intraoperative penile engorgement are also discussed.
- Conditions
- Anesthesia; Functional
- Being tested
- spinal anaesthesia
- Keywords
- Intraoperative penile engorgement, Anaesthesia, Urogenital surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anaesthesiaProcedure or surgery
Also called sedation
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative penile engorgement
Incidence of intraoperative penile engorgement under anaesthesia
Measured: sixty minutes from start of anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start15 Jan 2017
- Primary completion15 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; FunctionalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aligarh Muslim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUAZZAM HASAN, Aligarh Muslim University
- Investigators
- Muazzam Hasan, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438253
- Sponsor's protocol ID
- UWIPE
- Status last verified
- Feb 2018
- First submitted
- 10 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia: A Prospective Cohort Study to Discuss the Role of Anesthetic Technique and Other Common Contributing Factors.
- ClinicalTrials.gov ID
- NCT03438253
- Acronym / sponsor ID
- UWIPE
- Conditions
- Anesthesia; Functional
- Keywords
- Intraoperative penile engorgement, Anaesthesia, Urogenital surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Aligarh Muslim UniversityUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 19 Feb 2018 (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.
Penile engorgement during intraoperative period is of rare occurrence however when do happens, leads to difficulty in performing and even cancellation of elective urogenital surgery. The mechanism behind intraoperative penile engorgement is complex and involves various factors. One common myth is that penile engorgement occurs only during spinal anaesthesia and not in general anaesthesia. In this study we intend to report the incidence and management of intraoperative penile engorgement in pediatric patients undergoing urogenital operations under spinal anesthesia with/without sedation over a period of one year. The pathophysiology and role of common contributing factors leading to intraoperative penile engorgement are also discussed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 12 years
- Sex
- Male only
- Age groups
- Child
- Study population
- All ASA grade 1 \& 2 pediatric patients having age between 2 to 12 years.
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist grade1 \& 2
- Elective urogenital surgery of expected duration less than one hour
Key exclusion criteria (2 listed)
- patients with local infection, coagulation abnormalities, expected duration of surgery >1 hour and spinal anomalies.
- parents of patient not giving consent for spinal anaesthesia.
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 |
|---|---|---|
| spinal anaesthesiaAlso: sedation | Procedure or surgery | – |
Primary outcome
Intraoperative penile engorgement
Time frame: sixty minutes from start of anaesthesia
Incidence of intraoperative penile engorgement under anaesthesia
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 19 Feb 2018.
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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.
Muazzam Hasan, MD principal investigator
Assistant Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia; Functional, run by Aligarh Muslim University.
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 2 inclusion and 2 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Intraoperative penile engorgement (time frame: sixty minutes from start of anaesthesia). 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 19 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.