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Completed

NCT Number: NCT03438253

Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.

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.

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Key information

Conditions

Anesthesia; Functional

Age range

2 year–12 year

Sex eligibility

Male

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologist grade1 & 2
  • Elective urogenital surgery of expected duration less than one hour

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.

Treatment and study plan

spinal anaesthesia

Procedure

Other names: sedation

Primary outcomes

  1. Intraoperative penile engorgement

    Time frame: sixty minutes from start of anaesthesia

    Incidence of intraoperative penile engorgement under anaesthesia

Sponsors and collaborators

Lead sponsor

Aligarh Muslim University

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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