Adverse Reaction to Spinal AnestheticNCT02385539
Intrathecal Administration of Levobupivacaine and Opioids in Elderly
A study testing The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection. in people with Adverse Reaction to Spinal Anesthetic, run by Šarić, Jadranka Pavičić, M.D. at 1 site in Croatia.
Trial summary
To find the optimal dose and combination of small dose of Levobupivacaine (LB) coadministered intrathecally with Fentanyl (F) or Sufentanil (S) with the highest probability for not developing hypotension and the lowest opioid side effect that would be sufficient to achieve and maintain a sensory block to the tenth… Read more about this study
- Who is it for?
- Ages 65 to 95 years, men only
- Conditions the study is for
- Adverse Reaction to Spinal Anesthetic
- What is being tested?
- The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteCroatia
- Study dates
- Jan 2015to Sep 2016
- Phase
- Interventional
- 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 65 to 95 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- male patients
- ASA II-III undergoing elective urological (transuretheral or transvesical prostatectomy, hydrocelectomy, orchiectomy) or lower abdominal (inguinal herniorrhaphy) surgery under spinal anesthesia requiring a sensory block to at least the tenth thoracic dermatoma, lasting >45 minutes.
Who cannot join
- severe systemic disorders
- patients unwilling to accept regional anesthesia
- patients who will develope sensory block level lower than T10 dermatoma after intrathecal injection
- patients with an abnormal coagulation profile or with significant pulmonary disease (reactive airway disease or chronic obstructive pulmonary disease requiring daily bronchodilator or steroid use and/or room air oxygen saturation <95% immediately before surgery).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Anesthesia for Elderly Patients Undergoing Surgery Lasting >45 Minutes: A Randomized, Controlled, Dose and Combination Finding Study
To find the optimal dose and combination of small dose of Levobupivacaine (LB) coadministered intrathecally with Fentanyl (F) or Sufentanil (S) with the highest probability for not developing hypotension and the lowest opioid side effect that would be sufficient to achieve and maintain a sensory block to the tenth thoracic dermatoma (T10) in elderly patients for surgery lasting > 45 minutes as compared with large dose of Levobupivacaine alone.
Read the detailed description
Hypotension and bradycardia are the most common adverse hemodynamic effects associated with spinal anesthesia, with particular frequency among the elderly. These complications are more hazardous in the elderly because they may have decreased physiological reserves and compromised blood supply to various vital organs. Hypotension is mainly related to the spinal anesthesia block height. One approach to improve hemodynamic stability is to use smaller doses of local anesthetic (< 10 mg of Levobupivacaine) to limit the distribution of local anesthetic within the subarachnoid space and hence to limit the block height. However, a smaller dose of local anesthetic may increase the incidence of inadequate level of sensory anesthesia for the anticipated surgery as compared with larger doses (> 10 mg of Levobupivacaine). Another concern about smaller dose of local anesthetic is the inadequate duration of sensory anesthesia. Therefore, small dose of local anesthetic need to be combined with opioids (Fentanyl or Sufentanil). However, intrathecal opioids are associated with several side effects such as pruritis, nausea, vomiting, shivering and respiratory depression. This will be the first comparative study of two small doses of Levobupivacaine (6 and 8 mg) combined using intrathecal Fentanyl (F, 25 and 35 mcg) or Sufentanil (S, 5 and 7 mcg) compared with large dose of Levobupivacaine alone (12 mg) in spinal anesthesia. The study will be conducted to assess the impact of a 10 independent variables (dose and combination of Levobupivacaine with Fentanyl or Sufentanil, age, basal systolic blood pressure (SBP), basal mean arterial pressure (MAP), time to lowest spinal SBP, upper limit of sensory block (dermatome level), time intervals of sensory recovery for two consecutive dermatome level (two-segment regression), time intervals of sensory recovery to the twelfth thoracic dermatoma (T12 regression), time intervals of sensory recovery to the first sacral dermatoma (S1 regression) and Body Mass Index) on the likelihood of not developing hypotension after intrathecal injection. The goal of the study is to find an optimal dose and combination of Levobupivacaine and Fentanyl or Sufentanil with the highest probability of not developing the hypotension as well as with the lowest opioid side effect that would be potent enough in achieving and maintaining a sensory block at T10 level for surgery lasting more than 45 minutes in elderly patients.
- Conditions
- Adverse Reaction to Spinal Anesthetic
- Being tested
- The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.Drug
Also called levobupivacaine
The study will be conducted to assess the impact of a 10 independent variables (dose and combination of Levobupivacaine with Fentanyl or Sufentanil, age, basal systolic blood pressure (SBP), basal mean arterial pressure (MAP), time to lowest spinal SBP, upper limit of sensory block (dermatoma level), time intervals of sensory recovery for two consecutive dermatoma level (two-segment regression), time intervals of sensory recovery to the twelfth thoracic dermatoma (T12 regression), time intervals of sensory recovery to the first sacral dermatoma (S1 regression) and Body Mass Index) on the likelihood of not developing hypotension after intrathecal injection.
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine (LB) 6 mg | Active comparator | Patients will be stratified into three groups (80 patients) according to doses of Levobupivacaine (6, 8 or 12 mg, Chirocaine, Abbot Laboratories, amp. 5 mg/ml). Patients who will receive 6 mg of Levobupivacaine will be randomized to one of four treatment groups (each 20 patients), by dose of intrathecal opioids: 25, 35 mcg of Fentanyl (Fentanyl, Janssen Cilag, amp. 50 mcg/ml) or 5, 7 mcg of Sufentanil (Sufenta, Janssen-Pharmaceutica, amp. 5 mcg/ml). The groups will be named according to dose and combination of Levobupivacaine and Fentanyl or Sufentanil that will be given intrathecally as LB6F25 (LB 6 mg, Fentanyl 25 mcg), LB6F35 (LB 6 mg, Fentanyl 35 mcg), LB6S5 (LB 6 mg, Sufentanil 5 mcg), LB6S7 (LB 6 mg, Sufentanil 7 mcg). Hemodynamic and opioid's side effects will be recorded. The level and duration of sensory block, time until two-segment regression, T12 regression andl full skin sensory sensibility at the S1 segment will be registered Receives: Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection. |
| Levobupivacaine (LB) 8 mg | Active comparator | Patients will be stratified into three groups (80 patients) according to doses of Levobupivacaine (6, 8 or 12 mg, Chirocaine, Abbot Laboratories, amp. 5 mg/ml). Patients who will receive 8 mg of Levobupivacaine will be randomized to one of four treatment groups (each 20 patients), by dose of intrathecal opioids: 25, 35 mcg of Fentanyl (Fentanyl, Janssen Cilag, amp. 50 mcg/ml) or 5, 7 mcg of Sufentanil (Sufenta, Janssen-Pharmaceutica, amp. 5 mcg/ml). The groups will be named according to dose and combination of Levobupivacaine and Fentanyl or Sufentanil that will be given intrathecally as LB8F25 (LB 8 mg, Fentanyl 25 mcg), LB8F35 (LB 8 mg, Fentanyl 35 mcg), LB8S5 (LB 8 mg, Sufentanil 5 mcg), LB8S7 (LB 8 mg, Sufentanil 7 mcg). Hemodynamic and opioid's side effects will be recorded after intrathecal injection. The level and duration of sensory block, time until two-segment regression, T12 regression andl full skin sensory sensibility at the S1 segment will be registered Receives: Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection. |
| Levobupivacaine (LB) 12 mg | Placebo comparator | Patients will be stratified into three groups by 80 patients: those who will receive 6, 8 or 12 mg of Levobupivacaine intrathecally (Chirocaine, Abbot Laboratories, amp. 5 mg/ml). Patients will receive 12 mg of Levobupivacaine alone intrathecally.
Hemodynamic side effects will be recorded after intrathecal injection. The level and duration of sensory block, time until two-segment regression, T12 regression andl full skin sensory sensibility at the S1 segment will be registered Receives: Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal dose and combination of Levobupivacaine and Fentanyl or Sufentanil in elderly patients
To find an optimal dose and combination of Levobupivacaine and Fentanyl or Sufentanil with the highest probability of not developing the hypotension as well as with the lowest opioid side effect that would be potent enough in achieving and maintaining a sensory block at T10 level for surgery lasting more than 45 minutes in elderly patients. Binary logistic regression will be performed to assess the impact of a number of factors on the likelihood that patients may not develop hypotension. The model will consists of 10 independent variables (dose and combination of levobupivacaine with Fentanyl or Sufentanil, age, basal SBP, basal MAP, time to lowest spinal SBP, upper limit of sensory block, time until two-segment regression, time until T12 regression, time until S1 regression, BMI).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Reaction to Spinal AnestheticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Šarić, Jadranka Pavičić, M.D.
- Responsible party
- Sponsor
- Investigators
- Jadranka Pavičić Šarić, PhD, Principal investigator, University Hospital Merkur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385539
- Sponsor's protocol ID
- JPAVSAR
- Status last verified
- Apr 2017
- First submitted
- 2 Mar 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Anesthesia for Elderly Patients Undergoing Surgery Lasting >45 Minutes: A Randomized, Controlled, Dose and Combination Finding Study
- ClinicalTrials.gov ID
- NCT02385539
- Acronym / sponsor ID
- JPAVSAR
- Conditions
- Adverse Reaction to Spinal Anesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Šarić, Jadranka Pavičić, M.D.
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Mar 2015 (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 find the optimal dose and combination of small dose of Levobupivacaine (LB) coadministered intrathecally with Fentanyl (F) or Sufentanil (S) with the highest probability for not developing hypotension and the lowest opioid side effect that would be sufficient to achieve and maintain a sensory block to the tenth thoracic dermatoma (T10) in elderly patients for surgery lasting > 45 minutes as compared with large dose of Levobupivacaine alone.
Detailed description
Hypotension and bradycardia are the most common adverse hemodynamic effects associated with spinal anesthesia, with particular frequency among the elderly. These complications are more hazardous in the elderly because they may have decreased physiological reserves and compromised blood supply to various vital organs. Hypotension is mainly related to the spinal anesthesia block height. One approach to improve hemodynamic stability is to use smaller doses of local anesthetic (< 10 mg of Levobupivacaine) to limit the distribution of local anesthetic within the subarachnoid space and hence to limit the block height. However, a smaller dose of local anesthetic may increase the incidence of inadequate level of sensory anesthesia for the anticipated surgery as compared with larger doses (> 10 mg of Levobupivacaine). Another concern about smaller dose of local anesthetic is the inadequate duration of sensory anesthesia. Therefore, small dose of local anesthetic need to be combined with opioids (Fentanyl or Sufentanil). However, intrathecal opioids are associated with several side effects such as pruritis, nausea, vomiting, shivering and respiratory depression. This will be the first comparative study of two small doses of Levobupivacaine (6 and 8 mg) combined using intrathecal Fentanyl (F, 25 and 35 mcg) or Sufentanil (S, 5 and 7 mcg) compared with large dose of Levobupivacaine alone (12 mg) in spinal anesthesia. The study will be conducted to assess the impact of a 10 independent variables (dose and combination of Levobupivacaine with Fentanyl or Sufentanil, age, basal systolic blood pressure (SBP), basal mean arterial pressure (MAP), time to lowest spinal SBP, upper limit of sensory block (dermatome level), time intervals of sensory recovery for two consecutive dermatome level (two-segment regression), time intervals of sensory recovery to the twelfth thoracic dermatoma (T12 regression), time intervals of sensory recovery to the first sacral dermatoma (S1 regression) and Body Mass Index) on the likelihood of not developing hypotension after intrathecal injection. The goal of the study is to find an optimal dose and combination of Levobupivacaine and Fentanyl or Sufentanil with the highest probability of not developing the hypotension as well as with the lowest opioid side effect that would be potent enough in achieving and maintaining a sensory block at T10 level for surgery lasting more than 45 minutes in elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine (LB) 6 mg | Active comparator | Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.Patients will be stratified into three groups (80 patients) according to doses of Levobupivacaine (6, 8 or 12 mg, Chirocaine, Abbot Laboratories, amp. 5 mg/ml). Patients who will receive 6 mg of Levobupivacaine will be randomized to one of four treatment groups (each 20 patients), by dose of intrathecal opioids: 25, 35 mcg of Fentanyl (Fentanyl, Janssen Cilag, amp. 50 mcg/ml) or 5, 7 mcg of Sufentanil (Sufenta, Janssen-Pharmaceutica, amp. 5 mcg/ml). The groups will be named according to dose and combination of Levobupivacaine and Fentanyl or Sufentanil that will be given intrathecally as LB6F25 (LB 6 mg, Fentanyl 25 mcg), LB6F35 (LB 6 mg, Fentanyl 35 mcg), LB6S5 (LB 6 mg, Sufentanil 5 mcg), LB6S7 (LB 6 mg, Sufentanil 7 mcg). Hemodynamic and opioid's side effects will be recorded. The level and duration of sensory block, time until two-segment regression, T12 regression andl full skin sensory sensibility at the S1 segment will be registered |
| Levobupivacaine (LB) 8 mg | Active comparator | Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.Patients will be stratified into three groups (80 patients) according to doses of Levobupivacaine (6, 8 or 12 mg, Chirocaine, Abbot Laboratories, amp. 5 mg/ml). Patients who will receive 8 mg of Levobupivacaine will be randomized to one of four treatment groups (each 20 patients), by dose of intrathecal opioids: 25, 35 mcg of Fentanyl (Fentanyl, Janssen Cilag, amp. 50 mcg/ml) or 5, 7 mcg of Sufentanil (Sufenta, Janssen-Pharmaceutica, amp. 5 mcg/ml). The groups will be named according to dose and combination of Levobupivacaine and Fentanyl or Sufentanil that will be given intrathecally as LB8F25 (LB 8 mg, Fentanyl 25 mcg), LB8F35 (LB 8 mg, Fentanyl 35 mcg), LB8S5 (LB 8 mg, Sufentanil 5 mcg), LB8S7 (LB 8 mg, Sufentanil 7 mcg). Hemodynamic and opioid's side effects will be recorded after intrathecal injection. The level and duration of sensory block, time until two-segment regression, T12 regression andl full skin sensory sensibility at the S1 segment will be registered |
| Levobupivacaine (LB) 12 mg | Placebo comparator | Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.Patients will be stratified into three groups by 80 patients: those who will receive 6, 8 or 12 mg of Levobupivacaine intrathecally (Chirocaine, Abbot Laboratories, amp. 5 mg/ml). Patients will receive 12 mg of Levobupivacaine alone intrathecally. Hemodynamic side effects will be recorded after intrathecal injection. The level and duration of sensory block, time until two-segment regression, T12 regression andl full skin sensory sensibility at the S1 segment will be registered |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- male patients
- ASA II-III undergoing elective urological (transuretheral or transvesical prostatectomy, hydrocelectomy, orchiectomy) or lower abdominal (inguinal herniorrhaphy) surgery under spinal anesthesia requiring a sensory block to at least the tenth thoracic dermatoma, lasting >45 minutes.
Key exclusion criteria (4 listed)
- severe systemic disorders
- patients unwilling to accept regional anesthesia
- patients who will develope sensory block level lower than T10 dermatoma after intrathecal injection
- patients with an abnormal coagulation profile or with significant pulmonary disease (reactive airway disease or chronic obstructive pulmonary disease requiring daily bronchodilator or steroid use and/or room air oxygen saturation <95% immediately before surgery).
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 |
|---|---|---|
| The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.Also: levobupivacaineThe study will be conducted to assess the impact of a 10 independent variables (dose and combination of Levobupivacaine with Fentanyl or Sufentanil, age, basal systolic blood pressure (SBP), basal mean arterial pressure (MAP), time to lowest spinal SBP, upper limit of sensory block (dermatoma level), time intervals of sensory recovery for two consecutive dermatoma level (two-segment regression), time intervals of sensory recovery to the twelfth thoracic dermatoma (T12 regression), time intervals of sensory recovery to the first sacral dermatoma (S1 regression) and Body Mass Index) on the likelihood of not developing hypotension after intrathecal injection. | Drug | Levobupivacaine (LB) 12 mg, Levobupivacaine (LB) 6 mg, Levobupivacaine (LB) 8 mg |
Primary outcome
Optimal dose and combination of Levobupivacaine and Fentanyl or Sufentanil in elderly patients
Time frame: 9 months
To find an optimal dose and combination of Levobupivacaine and Fentanyl or Sufentanil with the highest probability of not developing the hypotension as well as with the lowest opioid side effect that would be potent enough in achieving and maintaining a sensory block at T10 level for surgery lasting more than 45 minutes in elderly patients. Binary logistic regression will be performed to assess the impact of a number of factors on the likelihood that patients may not develop hypotension. The model will consists of 10 independent variables (dose and combination of levobupivacaine with Fentanyl or Sufentanil, age, basal SBP, basal MAP, time to lowest spinal SBP, upper limit of sensory block, time until two-segment regression, time until T12 regression, time until S1 regression, BMI).
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 4 Apr 2017.
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.
Jadranka Pavičić Šarić, PhD principal investigator
University Hospital Merkur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection. in people with Adverse Reaction to Spinal Anesthetic, run by Šarić, Jadranka Pavičić, M.D. at 1 site in Croatia.
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 4 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 4 Apr 2017. 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 Croatia. 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. Some participants in this study may receive a placebo. 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?
Optimal dose and combination of Levobupivacaine and Fentanyl or Sufentanil in elderly patients (time frame: 9 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 4 Apr 2017.