Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.

• Sponsor: Aligarh Muslim University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03438253
• Collaborator: (none)
• Enrollment: 386
• Actual Duration (Months): 12.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Functional	Procedure: spinal anaesthesia

Study Design

• Study Type: Observational
• Actual Enrollment: 386 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official 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.
• Actual Study Start Date: Jan 15, 2017
• Actual Primary Completion Date: Jan 15, 2018
• Actual Study Completion Date: Jan 30, 2018

Outcome Measures

Primary Outcome Measures

1. Intraoperative penile engorgement [sixty minutes from start of anaesthesia]

   Incidence of intraoperative penile engorgement under anaesthesia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 12 Years
• Sexes Eligible for Study: Male

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aligarh Muslim University

Investigators

• Principal Investigator: Muazzam Hasan, MD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MUAZZAM HASAN, Assistant Professor, Aligarh Muslim University
• ClinicalTrials.gov Identifier: NCT03438253
• Other Study ID Numbers: UWIPE
• First Posted: Feb 19, 2018
• Last Update Posted: Feb 19, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by MUAZZAM HASAN, Assistant Professor, Aligarh Muslim University: Intraoperative penile engorgement; Anaesthesia; Urogenital surgery
• Additional relevant MeSH terms: Hyperemia; Anesthetics

Study Results

No Results Posted as of Feb 19, 2018