Neuromuscular Block Clinical Trial
Official title:
Comparison of Dexmetomidine's Efficacy as an Adjuvant to Intrathecal Levobupivacaine and Intravenous Administration Additionally to Spinal Anaesthesia, In Total Knee Arthroplasty
The present study is designed to evaluate and compare the efficacy of intrathecal dexmedetomidine (DEX) as an adjuvant to Levobupivacaine in spinal anaesthesia and DEX's intravenous administration, without loading dose, additionally to spinal anaesthesia, in patients undergoing total knee arthroplasty.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | September 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients selected for total knee arthroplasty of approximately one and half hour (90 min) duration under spinal anaesthesia. - Patients who belong to American Society of Anaesthesiologists (ASA) physical status grade I and II Exclusion Criteria:• Patients with coagulation and neurological disorders - Patients allergic to DEX - Patients showing unwillingness for spinal anaesthesia |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Kat General Hospital of Attca | Kifissia |
Lead Sponsor | Collaborator |
---|---|
KAT General Hospital |
Greece,
Chan IA, Maslany JG, Gorman KJ, O'Brien JM, McKay WP. Dexmedetomidine during total knee arthroplasty performed under spinal anesthesia decreases opioid use: a randomized-controlled trial. Can J Anaesth. 2016 May;63(5):569-76. doi: 10.1007/s12630-016-0597-y. — View Citation
Zhang H, Li M, Zhang SY, Fu M, Zhang SY. Intravenous Dexmedetomidine Promotes Spinal Bupivacaine Anesthesia and Postoperative Analgesia in Lower Limb Surgery: A Double-Blind, Randomized Clinical CONSORT Study. Medicine (Baltimore). 2016 Feb;95(8):e2880. doi: 10.1097/MD.0000000000002880. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Onset and duration of sensory block using the ' pin-prick ' method,in total knee athroplasty, using DEX as an adjuvant to intrathecal Levobuvicaine and iv administration additionally to spinal anesthesia with Levobuvicaine | By using a hypodermic needle at 2 min interval, we will assess the 'pin-prick' sensation from T12 to S1 The onset of sensory block will be tested by 'pin-prick method' using a hypodermic needle at 2 minutes interval. The time of onset will be taken from the time of injection of drug into subarachnoid space to loss of pinprick sensation to T12 level. We study 90 patients(ASAI-II) devided in 3 groups and we measure the highest level of sensory block, time for two dermatomal segments regression of sensory level, duration of sensory blockade taken as time from onset to time of return of pinprick sensation to S1 (heel) dermatomal area will be noted. | The time of onset will be taken from the time of injection of drug intrathecally to loss of pinprick sensation to T12 within 30 min. Duration of sensory blockade will be measured as time from onset to time of return of piniprick sensation to S1 level. | No |
Primary | Onset and duration of motor block using the Modified Bromage Scale, in total knee athroplasty, using DEX as an adjuvant to intrathecal Levobuvicaine and iv administration additionally to spinal anesthesia with Levobuvicaine | By using the Modified Bromage Scale we will assess the onset and duration of motor block. Grade 0 : Full flexion of knees and feet. Grade 1: Just able to flex knees, full flexion of feet. Grade 2: Unable to flex knees, but some flexion of feet possible. Grade 3; Unable to move legs or feet. | Onset time will be taken from the time of injection of drug intrathecally to the patient's inability to lift the extended leg within 30 min. The duration will be taken from time of injection of drug to the patient's ability to lift the extended leg. | No |
Primary | Duration of post-operative analgesia using the Visual Analogue Scale (VAS), in total knee arthroplasty, using DEX as an adjuvant to intrathecal Levobuvicaine and iv administration additionally to spinal anesthesia with Levobuvicaine | VAS is a scale from 0 to 10, with 0 indicating 'no pain' and 10 indicating the most severe pain, that somebody has experienced. Rescue analgesics will be given to the patients when VAS>3, which will be the cut-off point of our study. | We will record the post-operative analgesia using the Visual Analogue Scale (VAS) at the end of the surgery and 3, 6, 12,24 hours after the end of the surgeryn and at the end of the surgery. an interval of 3, 6 ,and 12 h after surgery | No |
Secondary | Hemodynamic stability of DEX, used as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anesthesia, in total knee arthroplasy | We will record SAP intra-operatively | SAP will be recorded at the time of the spinal injection, 10, 20, 30,45, 60 min after spinal injection and at the end of the surgery. | Yes |
Secondary | Hemodynamic stability of DEX, used as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anesthesia, in total knee arthroplasy | We will record DAP intra-operatively | DAP will be recorded will be recorded at the time of the spinal injection, 10, 20, 30,45, 60 min after spinal injection and at the end of the surgery. | Yes |
Secondary | Hemodynamic stability of DEX, used as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anesthesia, in total knee arthroplasy | We will record HR intra-operatively | HR will be recorded will be recorded at the time of the spinal injection, 10, 20, 30,45, 60 min after spinal injection and at the end of the surgery. | Yes |
Secondary | Adverse effects of DEX, used as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anaesthesia with Levobupivacaine, in total knee arthroplasy | We will record adverse effects like nausea, vomitting and shivering. | Adverse effects will be recorded will be recorded at the time of the spinal injection, 15, 30, 60 min after spinal injection, at the end of the surgery and 3, 6, 12, 24 hours after the end of the surgery | Yes |
Secondary | Sedation will be assessed with the Ramsay Sedation Scale, in total knee arthroplasty, by using DEX as an adjuvant to intrathecal Levobupivacaine and intravenous administration additionally to spinal anesthesia with Levobuvicaine | The Ramay Sedation Scale is : If awake : Ramsay 1 Anxious, agitated, restless Ramsay 2 Co-operative, oriented,tranquil, Ramsay 3 Responsive to commands only. If asleep: Ramsey 4 Brisk response to light glabellar tap or loud auditory stimulus Ramsey 5 Sluggish response to light glabellar tap or loud auditory stimulus Ramsey 6 No response to light glabellar tap or loud auditory stimulus | Sedation scores will be assessed will be recorded at the time of the spinal injection, 10, 20, 30,45, 60 min after spinal injection, at the end of the surgery and 30 minutes after the end of the surgery | No |
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