ClinicalTrials.gg
CompletedNCT03438253Updated Feb 19, 2018

Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.

An observational study in Anesthesia; Functional, sponsored by Aligarh Muslim University. Completed. Open to male participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by Aligarh Muslim University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
386
Ages
2 Years to 12 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Anesthesia; Functional

Keywords

  • Intraoperative penile engorgement
  • Anaesthesia
  • Urogenital surgery
03

In context

Lead sponsor

Aligarh Muslim University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
Male

Study population

All ASA grade 1 \& 2 pediatric patients having age between 2 to 12 years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • grade1 \& 2
  • Elective urogenital surgery of expected duration less than one hour

Exclusion criteria

Exclusion Criteria:

  • patients with local infection, coagulation abnormalities, expected duration of surgery >1 hour and spinal anomalies.
  • parents of patient not giving consent for spinal anaesthesia.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
386 participants (actual)
Patient registry
No

Interventions

  • Procedurespinal anaesthesia

    Also known as: sedation

06

What researchers measure

Primary outcomes

  1. Intraoperative penile engorgement

    Incidence of intraoperative penile engorgement under anaesthesia

    Time frame: sixty minutes from start of anaesthesia

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Jan 2018, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2018
First posted
Feb 19, 2018
StartActual
Jan 15, 2017
Primary completionActual
Jan 15, 2018
CompletionActual
Jan 30, 2018
Last update
Feb 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03438253
Lead sponsor
Aligarh Muslim University
Responsible party
MUAZZAM HASAN (Assistant Professor, Aligarh Muslim University) — Principal investigator
First posted
Feb 19, 2018
Start date
Jan 15, 2017
Primary completion
Jan 15, 2018
Completion
Jan 30, 2018
Last update
Feb 19, 2018

Study contacts

Muazzam Hasan, MD
principal investigator · Assistant Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion