Spinal or Intravenous Dexmedetomidine in Ambulatory Surgery
- Conditions
- Surgery Ambulatory
- Interventions
- Other: spinal chloroprocaine 40 mg
- Registration Number
- NCT02282319
- Lead Sponsor
- University Hospital, Antwerp
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- ASA (American Society of Anesthesiologists) class 1 & 2,
- undergoing day-case knee arthroscopy
- micturition problems,
- neurological history or
- previous lower abdominal surgery with an abnormal micturition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A chloro spinal chloroprocaine 40 mg spinal chloroprocaine 40 mg B chloro+ spin dexdor spinal dexmedetomidine 0.5 mcg Spinal chloroprocaine 40 mg spinal dexmedetomidine 0.5 mcg B chloro+ spin dexdor spinal chloroprocaine 40 mg Spinal chloroprocaine 40 mg spinal dexmedetomidine 0.5 mcg C chloro + IV dexdor spinal chloroprocaine 40 mg Spinal chloroprocaine 40 mg IV dexmedetomidine 0.5 mcg/kg C chloro + IV dexdor IV dexmedetomidine 0.5 mcg/kg Spinal chloroprocaine 40 mg IV dexmedetomidine 0.5 mcg/kg
- Primary Outcome Measures
Name Time Method sensory block regression L2 dermatome (minutes) (Time from injection until First time registration of loss of cold sensation) 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) 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
- Secondary Outcome Measures
Name Time Method time to micturition ( minutes) up to 240 minutes time from injection until first voiding
blood pressure drop 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
discharge time (minutes) up to 240 minutes time from spinal injection until achievement of discharge criteria
Trial Locations
- Locations (2)
Sint Augustinus
🇧🇪Wilrijk, Belgium
University Hospital Antwerp
🇧🇪Antwerp, Belgium