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NCT03438253 Clinical Trial

Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.

Anesthesia; Functional Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03438253
Other study ID # UWIPE
Secondary ID
Status Completed
Phase N/A
First received February 10, 2018
Last updated February 16, 2018
Start date January 15, 2017
Est. completion date January 30, 2018

Study information
Verified date February 2018
Source Aligarh Muslim University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 386
Est. completion date January 30, 2018
Est. primary completion date January 15, 2018
Accepts healthy volunteers
Gender Male
Age group 2 Years to 12 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• spinal anaesthesia

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Aligarh Muslim University

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative penile engorgement Incidence of intraoperative penile engorgement under anaesthesia sixty minutes from start of anaesthesia
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