Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.

NCT03438253 | Completed

• 1 other identifier: UWIPE
• Study Type: observational
• Target: 386
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anesthesia; Functional

Keywords

Intraoperative penile engorgement; Anaesthesia; Urogenital surgery

Outcome Measures

Primary Outcomes (1)

• Intraoperative penile engorgement

  Incidence of intraoperative penile engorgement under anaesthesia

  sixty minutes from start of anaesthesia

Interventions

spinal anaesthesia PROCEDURE

Also known as: sedation

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: male
• Age Groups: Child (0-17)

Study Population

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

You may qualify if:

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

You may not qualify if:

• patients with local infection, coagulation abnormalities, expected duration of surgery \>1 hour and spinal anomalies.
• parents of patient not giving consent for spinal anaesthesia.

Sponsors & Collaborators

• Aligarh Muslim University: lead

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Muazzam Hasan, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 19, 2018
• Study Start: January 15, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 30, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02