Spinal AnesthesiaNCT01609517
The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty
An observational study of Spinal Anesthesia and Success or Failure of Spinal Anesthesia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal anesthetic outcome by logistic regression analysis. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spinal Anesthesia, Success or Failure of Spinal Anesthesia
- What is being tested?
- Spinal anesthesia (heavy bupivacaine)
- How many people
- 209 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Dec 2012
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
Who may be able to join
- Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
- American Society of Anesthesiologist Physical Status classification I ~ III
Who cannot join
- Bupivacaine allergy
- medical history of spinal surgery
- Diabetic neuropathy
- active infection at the lumbosacral area
- other contraindication of spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
In these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal anesthetic outcome by logistic regression analysis.
Read the detailed description
Although the spread of spinal anesthetic drug is unpredictable, patients factors (age, gender, height,weight, body-mass index), spinal anatomy, anesthetic drug dose, and lumbosacral cerebrospinal fluid volume are known to be the determinants of sensory block level. Among these determinants, the influence of body-mass index (BMI) on spinal anesthesia is controversial, and there is no specific guideline showing the relative priority of these determinants.
Therefore, in these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the relative influence of these determinants on spinal anesthetic outcome by logistic regression analysis.
- Being tested
- Spinal anesthesia (heavy bupivacaine)
- Keywords
- Spinal anesthesia, determinant, duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia (heavy bupivacaine)Drug
Also called Spinal anesthesia, heavy bupivacaine
Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg
| Study group | Role | What they receive |
|---|---|---|
| Obese group | patients with BMI >= 30.0 kg/m2 who received spinal anesthesia with heavy marcaine Receives: Drug: Spinal anesthesia (heavy bupivacaine) | |
| Non-obese group | patients with BMI < 30.0 kg/m2 who received spinal anesthesia with heavy marcaine Receives: Drug: Spinal anesthesia (heavy bupivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
spinal anesthetic success/ failure
when (1) a bilateral T12 sensory block to pinprick within 15 minutes of intrathecal drug administration with sensory/motor block scale ≥ 2 and (2) the level of sensory block at the end of surgery was higher than or equal to T12 with sensory/motor block scale ≥ 2.
Measured: at 2 hour after the anesthetic induction
Secondary outcomes (4)
Peak level of sensory block at anesthesia induction
Sensory block levels determined by pinprick test
Measured: during 20 min after anesthetic induction
Spinal anesthesia sensory/motor block level at the end of surgery
Spinal anesthesia block level as determined by Pinprick sensory test with Bromage scale.
Sensory 0 = an ability to appreciate a pinprick as sharp; 1 = perception of a pinprick as less sharp than in unblocked areas; 2 = perception of a pinprick as touch but not sharp (analgesia); 3 = an inability to feel pinprick(anesthesia).
Bromage Scale 0 = ability to lift an extended knee at the hip; 1 = ability to flex the knee but not to lift an extended leg; 2 = ability to flex toes only; 3 = inability to move.
Measured: 2 hours after induction (at the end of surgery)
the incidence of tourniquet pain
the incidence of tourniquet pain during the tourniquet time reported by the patient (NRS >= 2)
Measured: at 90 min afer anesthetic induction
Incidence of hypotension, bradycardia
Incidence of hypotension, bradycardia total dose of ephedrine Lowest mean blood pressure Incidence of vomiting, shivering
Measured: during 2 hours after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangmin M. Lee, Samsung Medical Center
- Investigators
- Sangmin M. Lee, MD, PhD, Principal investigator, Samsung Medical CenterJi Sun Hahm, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609517
- Sponsor's protocol ID
- 2012-04-089-001
- Status last verified
- Oct 2014
- First submitted
- 29 May 2012
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty
- ClinicalTrials.gov ID
- NCT01609517
- Acronym / sponsor ID
- 2012-04-089-001
- Keywords
- Spinal anesthesia, determinant, duration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Jun 2012 (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.
In these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal anesthetic outcome by logistic regression analysis.
Detailed description
Although the spread of spinal anesthetic drug is unpredictable, patients factors (age, gender, height,weight, body-mass index), spinal anatomy, anesthetic drug dose, and lumbosacral cerebrospinal fluid volume are known to be the determinants of sensory block level. Among these determinants, the influence of body-mass index (BMI) on spinal anesthesia is controversial, and there is no specific guideline showing the relative priority of these determinants.
Therefore, in these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the relative influence of these determinants on spinal anesthetic outcome by logistic regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese group | – | Drug: Spinal anesthesia (heavy bupivacaine)patients with BMI >= 30.0 kg/m2 who received spinal anesthesia with heavy marcaine |
| Non-obese group | – | Drug: Spinal anesthesia (heavy bupivacaine)patients with BMI < 30.0 kg/m2 who received spinal anesthesia with heavy marcaine |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
Key inclusion criteria (2 listed)
- Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
- American Society of Anesthesiologist Physical Status classification I ~ III
Key exclusion criteria (5 listed)
- Bupivacaine allergy
- medical history of spinal surgery
- Diabetic neuropathy
- active infection at the lumbosacral area
- other contraindication of spinal anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesia (heavy bupivacaine)Also: Spinal anesthesia, heavy bupivacaineSpinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg | Drug | Non-obese group, Obese group |
Primary outcome
spinal anesthetic success/ failure
Time frame: at 2 hour after the anesthetic induction
when (1) a bilateral T12 sensory block to pinprick within 15 minutes of intrathecal drug administration with sensory/motor block scale ≥ 2 and (2) the level of sensory block at the end of surgery was higher than or equal to T12 with sensory/motor block scale ≥ 2.
4 secondary outcomes
Peak level of sensory block at anesthesia induction
Time frame: during 20 min after anesthetic induction
Spinal anesthesia sensory/motor block level at the end of surgery
Time frame: 2 hours after induction (at the end of surgery)
the incidence of tourniquet pain
Time frame: at 90 min afer anesthetic induction
Incidence of hypotension, bradycardia
Time frame: during 2 hours after anesthesia induction
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 30 Oct 2014.
Related trials for Spinal Anesthesia
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
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.
Sangmin M. Lee, MD, PhD principal investigator
Samsung Medical Center
Ji Sun Hahm, MD principal investigator
Samsung Medical Center
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 Spinal Anesthesia and Success or Failure of Spinal Anesthesia, run by Samsung Medical Center at 1 site in South Korea.
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 2 inclusion and 5 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 30 Oct 2014. 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 South Korea. 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?
spinal anesthetic success/ failure (time frame: at 2 hour after the anesthetic induction). 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 30 Oct 2014.