Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.

February 16, 2018 updated by: MUAZZAM HASAN, Aligarh Muslim University

Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia: A Prospective Cohort Study to Discuss the Role of Anesthetic Technique and Other Common Contributing Factors.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative penile engorgement
Time Frame: sixty minutes from start of anaesthesia
Incidence of intraoperative penile engorgement under anaesthesia
sixty minutes from start of anaesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aligarh Muslim University

Investigators

  • Principal Investigator: Muazzam Hasan, MD, Assistant professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2017

Primary Completion (Actual)

January 15, 2018

Study Completion (Actual)

January 30, 2018

Study Registration Dates

First Submitted

February 10, 2018

First Submitted That Met QC Criteria

February 16, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UWIPE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia; Functional

Clinical Trials on spinal anaesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe