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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

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Keywords

  • Intraoperative penile engorgement
  • Anaesthesia
  • Urogenital surgery
03

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.

Inclusion criteria

  • American Society of Anesthesiologist 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.
04

Study design

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

Interventions

  • Procedurespinal anaesthesia

    Also known as: sedation

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What researchers measure

Primary outcomes

  1. Intraoperative penile engorgement

    Incidence of intraoperative penile engorgement under anaesthesia

    Time frame: sixty minutes from start of anaesthesia

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Study locations

No study locations are listed for this record.

07

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 ↗

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

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