CryptorchidismNCT00435383
Comparing Oxygen Saturation in Post Anesthesia Care Unit After Different Methods of Pain Relief
An observational study of Cryptorchidism, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
To determine the which method of pain relief is better after current anesthesia care. Read more about this study
- Who is it for?
- Ages 1 year to 6 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cryptorchidism
- Type of treatment
- Injection or infusion
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Children scheduled for elective uni or bilateral orchidopexy.
Who may be able to join
- Healthy children
- ASA physical status 1 or 2
- 1-6 yr old
- Scheduled for elective uni or bilateral orchidopexy
Who cannot join
- Children with compromised pulmonary, cardiac, neurological, hematological, renal condition, with history of prematurely or are obese will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas,Anesthesiology Department
Houston, Texas, 77030
About this study
Official title: Oxygen Saturation During Transfer From Operating Room to Post Anesthesia Care Unit After Current Anesthesia Care
To determine the which method of pain relief is better after current anesthesia care.
Read the 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.
- Conditions
- Cryptorchidism
- Keywords
- Caudal Block, Oxygen Saturation, Uni or Bilateral Orchidopexy
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Group 1 received a presurgical caudal block and group 2 received a intravenous narcotics. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startMar 2003
- Primary completionFeb 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryptorchidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samia Khalil, The University of Texas Health Science Center, Houston
- Investigators
- Samia Khalil, M.D., Principal investigator, University of Texas, Houston, Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435383
- Sponsor's protocol ID
- HSC-MS-02-220
- Status last verified
- Dec 2015
- First submitted
- 13 Feb 2007
- Last updated
- 14 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Saturation During Transfer From Operating Room to Post Anesthesia Care Unit After Current Anesthesia Care
- ClinicalTrials.gov ID
- NCT00435383
- Acronym / sponsor ID
- HSC-MS-02-220
- Conditions
- Cryptorchidism
- Keywords
- Caudal Block, Oxygen Saturation, Uni or Bilateral Orchidopexy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Feb 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 15 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –Group 1 received a presurgical caudal block and group 2 received a intravenous narcotics. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children scheduled for elective uni or bilateral orchidopexy.
Key inclusion criteria (4 listed)
- Healthy children
- ASA physical status 1 or 2
- 1-6 yr old
- Scheduled for elective uni or bilateral orchidopexy
Key exclusion criteria (1 listed)
- Children with compromised pulmonary, cardiac, neurological, hematological, renal condition, with history of prematurely or are obese will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samia Khalil, M.D. principal investigator
University of Texas, Houston, Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptorchidism, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.