Knee Replacement SurgeryNCT01213602
Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery
An observational study of Knee Replacement Surgery, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The principal objective is to notice the relevance of timing performance of femoral block for knee replacement surgery during general anesthesia and analyze the relationship with bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Knee Replacement Surgery
- How many people
- 85 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Feb 2011
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA physical status I-III patients scheduled for total knee arthoplasty
Who may be able to join
- -
Who cannot join
- ASA IV, patients with difficult airway management, patients with antecedent of cerebral ischemia, presence of atrioventricular fistula, patients with absent distal pulses or history of vascular surgery in the involved limbs, patients with high risk of deep vein thrombosis.-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Bispectral Index Changes During Knee Replacement Surgery With and Without Femoral Block
The principal objective is to notice the relevance of timing performance of femoral block for knee replacement surgery during general anesthesia and analyze the relationship with bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia. Otherwise the investigators try to investigate if the timing of performance of this block influence in postoperative variables as pain or blood loss.
- Conditions
- Knee Replacement Surgery
- Keywords
- Trauma patients
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 |
|---|---|---|
| Femoral block preoperative | In one group (T1) with performance of femoral block before general anesthesia and administration of bolus of local anesthetic through stimulating catheter (combined anesthesia) | |
| Femoral block postoperative | In second group (T2) with a administration of local anesthetic through stimulating femoral catheter until awareness of patient (balanced anesthesia). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sevoflurane requirements
Combined ( femoral block and general anesthesia) or balanced anesthesia ( intravenous analgesics and general anesthesia) is evaluated on the requirements of inhalational hypnotics during surgery. Schedule time when BIS has to be in proper range (40-60): T1 T2 T3 T4 T5 T6
T1 Induction T2 Inflated cuff ischemia T3 Incision T4 Unlocking cuff ischemia T5 End surgery T6 Time to wake the patient from the close of the sevoflurane vaporizer
Each time include a period of adjustment in 5 minutes
Measured: 6 months
Secondary outcomes (1)
Intraoperative and postoperative opiates requirements and relations with CVI
Measured: Time surgery and 24,48 and 72 h postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Replacement SurgeryStudies 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Investigators
- Antoni Sabate Pes, MD PhD DEEA, Principal investigator, Hospital Universitari Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213602
- Sponsor's protocol ID
- SAB-ANE-2010-01
- Status last verified
- Feb 2011
- First submitted
- 1 Oct 2010
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Bispectral Index Changes During Knee Replacement Surgery With and Without Femoral Block
- ClinicalTrials.gov ID
- NCT01213602
- Acronym / sponsor ID
- SAB-ANE-2010-01
- Conditions
- Knee Replacement Surgery
- Keywords
- Trauma patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 4 Oct 2010 (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.
The principal objective is to notice the relevance of timing performance of femoral block for knee replacement surgery during general anesthesia and analyze the relationship with bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia. Otherwise the investigators try to investigate if the timing of performance of this block influence in postoperative variables as pain or blood loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral block preoperative | – | –In one group (T1) with performance of femoral block before general anesthesia and administration of bolus of local anesthetic through stimulating catheter (combined anesthesia) |
| Femoral block postoperative | – | –In second group (T2) with a administration of local anesthetic through stimulating femoral catheter until awareness of patient (balanced anesthesia). |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA physical status I-III patients scheduled for total knee arthoplasty
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- ASA IV, patients with difficult airway management, patients with antecedent of cerebral ischemia, presence of atrioventricular fistula, patients with absent distal pulses or history of vascular surgery in the involved limbs, patients with high risk of deep vein thrombosis.-
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
Sevoflurane requirements
Time frame: 6 months
Combined ( femoral block and general anesthesia) or balanced anesthesia ( intravenous analgesics and general anesthesia) is evaluated on the requirements of inhalational hypnotics during surgery. Schedule time when BIS has to be in proper range (40-60): T1 T2 T3 T4 T5 T6 T1 Induction T2 Inflated cuff ischemia T3 Incision T4 Unlocking cuff ischemia T5 End surgery T6 Time to wake the patient from the close of the sevoflurane vaporizer Each time include a period of adjustment in 5 minutes
1 secondary outcome
Intraoperative and postoperative opiates requirements and relations with CVI
Time frame: Time surgery and 24,48 and 72 h postoperative
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 25 Jul 2011.
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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.
Antoni Sabate Pes, MD PhD DEEA principal investigator
Hospital Universitari Bellvitge
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 Knee Replacement Surgery, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 1 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 25 Jul 2011. 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 Spain. 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.
What does the primary outcome measure?
Sevoflurane requirements (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 25 Jul 2011.