Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.

Completed

• Conditions: Anesthesia; Functional

• Registration Number: NCT03438253
• Lead Sponsor: Aligarh Muslim University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-15
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-30
• Status Verified: 2018-02
• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-02-16
• Last Update Submitted: 2018-02-16
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 386

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraoperative penile engorgement	sixty minutes from start of anaesthesia	Incidence of intraoperative penile engorgement under anaesthesia