Comparing Oxygen Saturation in Post Anesthesia Care Unit... | NCT00435383

Studies
Comparing Oxygen Saturation in Post Anesthesia Care Unit After Different Methods of Pain Relief

NCT00435383

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Dec 14, 2015Estimated

Enrollment

42Estimated

Phase

Not provided

Conditions

Cryptorchidism

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Feb 2007Actual

Completion Date

Oct 2008Actual

First Submitted Date

Feb 13, 2007

First Submission Date that Met QC Criteria

Feb 14, 2007

First Posted Date

Feb 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2015

Last Update Posted Date

Dec 14, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Samia Khalil, Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Description Module

Brief Summary

To determine the which method of pain relief is better after current anesthesia care.

Detailed Description

We hypothesized that in children, the current anesthesia care (combined light general anesthesia and caudal analgesia) may decrease incidence of intra and or postoperative de-saturation( SaO2 < %95), the need of oxygen during child's transport to the PACU and during his stay in the recovery room, compared with children who receive intravenous narcotics for intra and postoperative pain relief.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Group 1 received a presurgical caudal block and group 2 received a intravenous narcotics.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy children
ASA physical status 1 or 2
1-6 yr old
Scheduled for elective uni or bilateral orchidopexy

Exclusion Criteria:

Children with compromised pulmonary, cardiac, neurological, hematological, renal condition, with history of prematurely or are obese will be excluded.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

6 Years

Standard Ages

Child

Study Population

Children scheduled for elective uni or bilateral orchidopexy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samia Khalil, M.D.	University of Texas, Houston, Texas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas,Anesthesiology Department		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D003456	Cryptorchidism

Ancestor Terms

ID	Term
D013733	Testicular Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided