- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02282319
Spinal or Intravenous Dexmedetomidine in Ambulatory Surgery
Influence of Spinal or Intravenous Dexmedetomidine on Spinal Anesthesia With Chloroprocaine and Bladder Function in Day-case Surgery. A Double Blind Randomized Study.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Antwerp, Belgium, 2650
- University hospital Antwerp
-
Wilrijk, Belgium, 2610
- Sint Augustinus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA (American Society of Anesthesiologists) class 1 & 2,
- undergoing day-case knee arthroscopy
Exclusion Criteria:
- micturition problems,
- neurological history or
- previous lower abdominal surgery with an abnormal micturition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A chloro
spinal chloroprocaine 40 mg
|
spinal anesthesia with chloroprocaine 40 mg
Other Names:
|
Experimental: B chloro+ spin dexdor
Spinal chloroprocaine 40 mg spinal dexmedetomidine 0.5 mcg
|
spinal anesthesia with chloroprocaine 40 mg
Other Names:
Administration of dexmedetomidine 0.5 mcg
Other Names:
|
Experimental: C chloro + IV dexdor
Spinal chloroprocaine 40 mg IV dexmedetomidine 0.5 mcg/kg
|
spinal anesthesia with chloroprocaine 40 mg
Other Names:
intravenous administration of dexmedetomidine 0.5 mcg/kg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 360 minutes
|
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
|
up to 240 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
discharge time (minutes)
Time Frame: up to 240 minutes
|
time from spinal injection until achievement of discharge criteria
|
up to 240 minutes
|
time to micturition ( minutes)
Time Frame: up to 240 minutes
|
time from injection until first voiding
|
up to 240 minutes
|
blood pressure drop
Time Frame: up to 240 minutes
|
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
|
up to 240 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
micturition problems (scaling based on bladder volumes and subjective difficulties) in a 1-5 point scale
Time Frame: at discharge ( up to 240 minutes)
|
classification of problems ( scaling based on bladder volumes and subjective difficulties) in a 1-5 point scale
|
at discharge ( up to 240 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: margaretha breebaart, MD, University Hospital, Antwerp
- Principal Investigator: Marcel Vercauteren, MD, PHD, University Hospital, Antwerp
Publications and helpful links
General 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.
- Breebaart 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Dexmedetomidine
- Chloroprocaine
Other Study ID Numbers
- 13/35/334
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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