Laparoscopic CholecystectomyNCT00914875
Kidney Function After Pneumoperitoneum and Analgesia
An observational study of Laparoscopic Cholecystectomy, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
double blind study of kidney function of two groups of adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- How many people
- 126 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2007to Dec 2007
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol plus ketorolac or dypirone
Who may be able to join
- From 18 to 60 years
- Normal kidney function
- Free consented participation
Who cannot join
- Renal and hepatic dysfunction
- Prior (one month) use of anti-inflammatory agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kidney Function After Laparoscopic Cholecystectomy and Tramadol Anesthesia Plus Dipyrone or Ketorolac
double blind study of kidney function of two groups of adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac
Read the detailed description
Background: The laparoscopic cholecystectomy (LC) reduces surgical trauma and hospital stay but requires effective and safe postoperative analgesia. This prospective and double blind study aimed to study the effects of tramadol analgesia associated to dipyrone or ketorolac in the kidney function of patients submitted to LC, using creatinine (Cr), cystatin C, and enzymuria evaluations.
Methods: In the pre- and postoperative (PO) periods, estimated glomerular filtration rates (GFR), obtained from two formulas dependants of blood Cr and one from blood cystatin C values, and tubular enzymuria - alkaline phosphatase (AP), γ-glutamyltransferase (γ-GT) - were determined in patients who underwent LC and analgesia with tramadol and dipyrone (G1, n=63) or tramadol and ketorolac (G2, n=63). In the recovery room (RR), pain and need of rescue analgesia with morphine were evaluated.
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- kidney function tests, anti-inflammatory agents, non-steroidal, laparoscopic cholecystectomy, adult
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 |
|---|---|---|
| group tramadol plus ketorolac | Not described | |
| group tramadol plus dypirone | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Yara M Castiglia, MD, PhD, Principal investigator, Botucatu Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914875
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-25
- Status last verified
- Jun 2009
- First submitted
- 3 Jun 2009
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Function After Laparoscopic Cholecystectomy and Tramadol Anesthesia Plus Dipyrone or Ketorolac
- ClinicalTrials.gov ID
- NCT00914875
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-25
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- kidney function tests, anti-inflammatory agents, non-steroidal, laparoscopic cholecystectomy, adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Jun 2009 (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.
double blind study of kidney function of two groups of adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac
Detailed description
Background: The laparoscopic cholecystectomy (LC) reduces surgical trauma and hospital stay but requires effective and safe postoperative analgesia. This prospective and double blind study aimed to study the effects of tramadol analgesia associated to dipyrone or ketorolac in the kidney function of patients submitted to LC, using creatinine (Cr), cystatin C, and enzymuria evaluations.
Methods: In the pre- and postoperative (PO) periods, estimated glomerular filtration rates (GFR), obtained from two formulas dependants of blood Cr and one from blood cystatin C values, and tubular enzymuria - alkaline phosphatase (AP), γ-glutamyltransferase (γ-GT) - were determined in patients who underwent LC and analgesia with tramadol and dipyrone (G1, n=63) or tramadol and ketorolac (G2, n=63). In the recovery room (RR), pain and need of rescue analgesia with morphine were evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group tramadol plus ketorolac | – | – |
| group tramadol plus dypirone | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol plus ketorolac or dypirone
Key inclusion criteria (3 listed)
- From 18 to 60 years
- Normal kidney function
- Free consented participation
Key exclusion criteria (2 listed)
- Renal and hepatic dysfunction
- Prior (one month) use of anti-inflammatory agents
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 5 Jun 2009.
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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.
Yara M Castiglia, MD, PhD principal investigator
Botucatu Medical School
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 Laparoscopic Cholecystectomy, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 3 inclusion and 2 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 5 Jun 2009. 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 Brazil. 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 5 Jun 2009.