Surgery AmbulatoryPhase 4NCT02282319
Spinal or Intravenous Dexmedetomidine in Ambulatory Surgery
A Phase 4 study testing spinal dexmedetomidine 0.5 mcg, spinal chloroprocaine 40 mg and IV dexmedetomidine 0.5 mcg/kg in people with Surgery Ambulatory, run by University Hospital, Antwerp at 2 sites in Belgium.
Trial summary
The primary objective of this double blind randomized study is to determine the effect of dexmedetomidine on onset and duration of the sensory and motor block and on the influence on bladder function after spinal anesthesia with chloroprocaine. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery Ambulatory
- What is being tested?
- spinal dexmedetomidine 0.5 mcg, spinal chloroprocaine 40 mg and IV dexmedetomidine 0.5 mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesBelgium
- Study dates
- Oct 2014to Dec 2020
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anesthesiologists) class 1 \& 2,
- undergoing day-case knee arthroscopy
Who cannot join
- micturition problems,
- neurological history or
- previous lower abdominal surgery with an abnormal micturition
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital Antwerp
Antwerp, 2650
Sint Augustinus
Wilrijk, 2610
About this study
Official title: Influence of Spinal or Intravenous Dexmedetomidine on Spinal Anesthesia With Chloroprocaine and Bladder Function in Day-case Surgery. A Double Blind Randomized Study.
The primary objective of this double blind randomized study is to determine the effect of dexmedetomidine on onset and duration of the sensory and motor block and on the influence on bladder function after spinal anesthesia with chloroprocaine. Our primary hypothesis is that sensory block will significantly be prolonged by dexmedetomidine administered by both the spinal and the intravenous route. The investigators do not expect a significant difference in motor block duration between intravenous or spinal administration. Secondary outcomes are micturition problems, duration of analgesia and the occurrence of side effects such as sedation and hypotension.
Read the detailed description
The study is designed as a multicenter study and randomization and inclusion of patients will be performed in three hospitals. Each hospital has its own randomisation sequence and coordinating investigator who will be responsible for appointing blinded and unblinded participators in the study.
Patients scheduled for spinal anesthesia in ambulatory surgery will be randomized by sealed envelopes (computer generated sequence) into one of the following three study groups:
spinal chloroprocaine 40 mg with spinal dexmedetomidine (5mcg) spinal chloroprocaine 40 mg with intravenous dexmedetomidine ( 0.5 mcg/kg) spinal chloroprocaine 40 mg alone (control group)
All patients will receive the same amount of spinal solution, containing chloroprocaine 1% (4 ml) with dexmedetomidine (0.5 ml, 1 mcg/ml) or NaCl ( sodiumchloride) 0,9% (0.5 ml ) ( and 50 ml intravenous Nacl 0.9, containing dexmedetomidine (0.5 mcg/kg) or not depending on the study group. All solutions are prepared by an independent anesthesiologist and labelled as Intravenous study medication and spinal study medication. Spinal anesthesia and data registration will be done by a blinded anesthesist and/or study nurse on a data sheet designed for the study.
Spinal anesthesia is performed in the lateral decubitus at L3-L4 vertebral interspace and standard monitoring for this procedure is applied. Insufficient analgesia will be treated with sufentanil increments. Hypotension and bradycardia will be treated with ephedrine and atropine. Patients will be discharged when the block is regressed, there is no sedation or nausea and nrs scores of pain are below 4. Patients will be contacted by telephone after one week to evaluate any postoperative complaints.Micturition will receive a score based on bladder volumes measured by bladder scanning and subjective complaints . This score system was used in two of our former studies (1,2)
To calculate the power of this study, we used the mean L2 regression of a previous study after spinal chloroprocaine with its standard deviation (SD 20 min, mean 90 min) and compared it to a mean increase with 30 %. We calculated that we should include 7 patients in each group to obtain a power of 80%.
To be sure to detect a possible difference in discharge time as well, we calculated a sample size of 48 patients for each group to detect a 30-minute difference.
Statistical analysis will be done with ANOVA analysis , A kruskal-Wallis of Mann Whitney test depending on the distribution of the population and if the values are parametric or not. This will be done by spss.
- Conditions
- Surgery Ambulatory
- Being tested
- spinal dexmedetomidine 0.5 mcg, spinal chloroprocaine 40 mg, IV dexmedetomidine 0.5 mcg/kg
- Keywords
- spinal or intravenous dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal dexmedetomidine 0.5 mcgDrug
Also called dexdor
Administration of dexmedetomidine 0.5 mcg
spinal chloroprocaine 40 mgOther
Also called ampres
spinal anesthesia with chloroprocaine 40 mg
IV dexmedetomidine 0.5 mcg/kgDrug
Also called dexdor
intravenous administration of dexmedetomidine 0.5 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| A chloro | Experimental | spinal chloroprocaine 40 mg Receives: Other: spinal chloroprocaine 40 mg |
| B chloro+ spin dexdor | Experimental | Spinal chloroprocaine 40 mg spinal dexmedetomidine 0.5 mcg Receives: Drug: spinal dexmedetomidine 0.5 mcg; Other: spinal chloroprocaine 40 mg |
| C chloro + IV dexdor | Experimental | Spinal chloroprocaine 40 mg IV dexmedetomidine 0.5 mcg/kg Receives: Other: spinal chloroprocaine 40 mg; Drug: IV dexmedetomidine 0.5 mcg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory block regression L2 dermatome (minutes) (Time from injection until First time registration of loss of cold sensation)
Time from injection until First time registration of loss of cold sensation at the L2 dermatome during block regression. Loss of cold sensation will be regularly assessed from spinal injection until total regression of the sensory block
Measured: up to 360 minutes
Motor block regression (minutes) (time from injection until achievement of active knee movement)
time from injection until achievement of active knee movement during block regression. Motor block will be assessed at regular intervals from spinal injection untill total regression of the motor block
Measured: up to 240 minutes
Secondary outcomes (3)
discharge time (minutes)
time from spinal injection until achievement of discharge criteria
Measured: up to 240 minutes
time to micturition ( minutes)
time from injection until first voiding
Measured: up to 240 minutes
blood pressure drop
percentage of drop blood pressure compared to base line ( measured before spinal injection) . Blood pressure will be measured at regular intervals from just prior to spinal injection until discharge
Measured: up to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgery AmbulatoryStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr M. B. Breebaart, University Hospital, Antwerp
- Investigators
- margaretha breebaart, MD, Principal investigator, University Hospital, AntwerpMarcel Vercauteren, MD, PHD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282319
- Sponsor's protocol ID
- 13/35/334
- Status last verified
- Aug 2022
- First submitted
- 30 Oct 2014
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Breebaart MB, Vercauteren MP, Hoffmann VL, Adriaensen HA. Urinary bladder scanning after day-case arthroscopy under spinal anaesthesia: comparison between lidocaine, ropivacaine, and levobupivacaine. Br J Anaesth. 2003 Mar;90(3):309-13. doi: 10.1093/bja/aeg078.
PubMed 12594142Breebaart MB, Teune A, Sermeus LA, Vercauteren MP. Intrathecal chloroprocaine vs. lidocaine in day-case surgery: recovery, discharge and effect of pre-hydration on micturition. Acta Anaesthesiol Scand. 2014 Feb;58(2):206-13. doi: 10.1111/aas.12247.
PubMed 24563922
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Spinal or Intravenous Dexmedetomidine on Spinal Anesthesia With Chloroprocaine and Bladder Function in Day-case Surgery. A Double Blind Randomized Study.
- ClinicalTrials.gov ID
- NCT02282319
- Acronym / sponsor ID
- 13/35/334
- Conditions
- Surgery Ambulatory
- Keywords
- spinal or intravenous dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 4 Nov 2014 (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 primary objective of this double blind randomized study is to determine the effect of dexmedetomidine on onset and duration of the sensory and motor block and on the influence on bladder function after spinal anesthesia with chloroprocaine. Our primary hypothesis is that sensory block will significantly be prolonged by dexmedetomidine administered by both the spinal and the intravenous route. The investigators do not expect a significant difference in motor block duration between intravenous or spinal administration. Secondary outcomes are micturition problems, duration of analgesia and the occurrence of side effects such as sedation and hypotension.
Detailed description
The study is designed as a multicenter study and randomization and inclusion of patients will be performed in three hospitals. Each hospital has its own randomisation sequence and coordinating investigator who will be responsible for appointing blinded and unblinded participators in the study.
Patients scheduled for spinal anesthesia in ambulatory surgery will be randomized by sealed envelopes (computer generated sequence) into one of the following three study groups:
spinal chloroprocaine 40 mg with spinal dexmedetomidine (5mcg) spinal chloroprocaine 40 mg with intravenous dexmedetomidine ( 0.5 mcg/kg) spinal chloroprocaine 40 mg alone (control group)
All patients will receive the same amount of spinal solution, containing chloroprocaine 1% (4 ml) with dexmedetomidine (0.5 ml, 1 mcg/ml) or NaCl ( sodiumchloride) 0,9% (0.5 ml ) ( and 50 ml intravenous Nacl 0.9, containing dexmedetomidine (0.5 mcg/kg) or not depending on the study group. All solutions are prepared by an independent anesthesiologist and labelled as Intravenous study medication and spinal study medication. Spinal anesthesia and data registration will be done by a blinded anesthesist and/or study nurse on a data sheet designed for the study.
Spinal anesthesia is performed in the lateral decubitus at L3-L4 vertebral interspace and standard monitoring for this procedure is applied. Insufficient analgesia will be treated with sufentanil increments. Hypotension and bradycardia will be treated with ephedrine and atropine. Patients will be discharged when the block is regressed, there is no sedation or nausea and nrs scores of pain are below 4. Patients will be contacted by telephone after one week to evaluate any postoperative complaints.Micturition will receive a score based on bladder volumes measured by bladder scanning and subjective complaints . This score system was used in two of our former studies (1,2)
To calculate the power of this study, we used the mean L2 regression of a previous study after spinal chloroprocaine with its standard deviation (SD 20 min, mean 90 min) and compared it to a mean increase with 30 %. We calculated that we should include 7 patients in each group to obtain a power of 80%.
To be sure to detect a possible difference in discharge time as well, we calculated a sample size of 48 patients for each group to detect a 30-minute difference.
Statistical analysis will be done with ANOVA analysis , A kruskal-Wallis of Mann Whitney test depending on the distribution of the population and if the values are parametric or not. This will be done by spss.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A chloro | Experimental | Other: spinal chloroprocaine 40 mgspinal chloroprocaine 40 mg |
| B chloro+ spin dexdor | Experimental | Drug: spinal dexmedetomidine 0.5 mcg, Other: spinal chloroprocaine 40 mgSpinal chloroprocaine 40 mg spinal dexmedetomidine 0.5 mcg |
| C chloro + IV dexdor | Experimental | Other: spinal chloroprocaine 40 mg, Drug: IV dexmedetomidine 0.5 mcg/kgSpinal chloroprocaine 40 mg IV dexmedetomidine 0.5 mcg/kg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA (American Society of Anesthesiologists) class 1 \& 2,
- undergoing day-case knee arthroscopy
Key exclusion criteria (3 listed)
- micturition problems,
- neurological history or
- previous lower abdominal surgery with an abnormal micturition
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 dexmedetomidine 0.5 mcgAlso: dexdorAdministration of dexmedetomidine 0.5 mcg | Drug | B chloro+ spin dexdor |
| spinal chloroprocaine 40 mgAlso: ampresspinal anesthesia with chloroprocaine 40 mg | Other | A chloro, B chloro+ spin dexdor, C chloro + IV dexdor |
| IV dexmedetomidine 0.5 mcg/kgAlso: dexdorintravenous administration of dexmedetomidine 0.5 mcg/kg | Drug | C chloro + IV dexdor |
Primary outcome
sensory block regression L2 dermatome (minutes) (Time from injection until First time registration of loss of cold sensation)
Time frame: up to 360 minutes
Time from injection until First time registration of loss of cold sensation at the L2 dermatome during block regression. Loss of cold sensation will be regularly assessed from spinal injection until total regression of the sensory block
Motor block regression (minutes) (time from injection until achievement of active knee movement)
Time frame: up to 240 minutes
time from injection until achievement of active knee movement during block regression. Motor block will be assessed at regular intervals from spinal injection untill total regression of the motor block
3 secondary outcomes
discharge time (minutes)
Time frame: up to 240 minutes
time to micturition ( minutes)
Time frame: up to 240 minutes
blood pressure drop
Time frame: up to 240 minutes
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 Aug 2022.
- Background: PubMed 12594142Breebaart MB, Vercauteren MP, Hoffmann VL, Adriaensen HA. Urinary bladder scanning after day-case arthroscopy under spinal anaesthesia: comparison between lidocaine, ropivacaine, and levobupivacaine. Br J Anaesth. 2003 Mar;90(3):309-13. doi: 10.1093/bja/aeg078.
- Background: PubMed 24563922Breebaart MB, Teune A, Sermeus LA, Vercauteren MP. Intrathecal chloroprocaine vs. lidocaine in day-case surgery: recovery, discharge and effect of pre-hydration on micturition. Acta Anaesthesiol Scand. 2014 Feb;58(2):206-13. doi: 10.1111/aas.12247.
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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.
margaretha breebaart, MD principal investigator
University Hospital, Antwerp
Marcel Vercauteren, MD, PHD principal investigator
University Hospital, Antwerp
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing spinal dexmedetomidine 0.5 mcg, spinal chloroprocaine 40 mg and IV dexmedetomidine 0.5 mcg/kg in people with Surgery Ambulatory, run by University Hospital, Antwerp at 2 sites in Belgium.
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 3 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
sensory block regression L2 dermatome (minutes) (Time from injection until First time registration of loss of cold sensation) (time frame: up to 360 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02282319, which also lists 2 linked publications.
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 Aug 2022.