Comparison Between Intrathecal and Intravenous Dexmedetomidine

Study Overview
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Brief Summary
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A prospective, randomized, comparative controlled clinical trial, aiming to compare the use of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.

Detailed Description
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Seventy patients undergoing lower limb surgeries were included in this study. Using a random number sequence, patients were enrolled in one of two groups: Group T receiving 5 µg of dexmedetomidine (Precedex® 100 µg/mL, Hospira, Inc., IL, U.S.A.) combined with 12.5 mg of 0.5% hyperbaric bupivacaine (Marcaine® Spinal Heavy; Astra, Sodertalje, Sweden) and Group V receiving the same bupivacaine DOSE AND 0.75 microgram/kilogram of body weight dexmedetomidine intravenously. Dexmedetomidine 100 µg/mL was mixed with preservative-free normal saline to 10 µg/mL. The 0.5 mL of dilute dexmedetomidine was added to the bupivacaine in group T. An independent investigator prepared the drug solutions and provided the coded drug to the anaesthetic administrator before the start of the anaesthesia. The anaesthetic administrator, patients, outcome assessors, and data analysts were blinded to the allocation. Spinal Anesthesia Patients were hydrated with 500 mL of 0.9% sodium chloride solution before anaesthesia. The spinal puncture was performed at L3-4 or L4-5 with a midline approach using a 25 G Quincke needle in the lateral decubitus position. After confirmation of free flow and clear cerebrospinal fluid, the drug was administered and the patients were then placed in the supine neutral position. Assessment: The primary end-point of this study was the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.

Official Title
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Comparison Study Between Intrathecal and Intravenous Dexmedetomidine in Lower Limb Surgeries

Conditions
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Postoperative Analgesia

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II patients age 18-65 years scheduled for lower limb surgery spinal anaesthesia Exclusion Criteria: patients with coagulopathy infection at the site of lumbar puncture beta-blockers or calcium channel blockers usage hypersensitivity to Bupivacaine or Dexmedetomidine any other contra-indications for spinal anaesthesia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IT intrathecal<br>administration of intrathecal dexmedetomidine in addition to bupivacaine for lower limb surgeries | Drug: Dexmedetomidine<br>* INTRATHECAL AND INTRAVENOUS<br>* Other names: precidex;|
| Active Comparator: IV intravenous<br>administration of intravenous dexmedetomidine in addition to spinal anaesthesia for lower limb surgeries | Drug: Dexmedetomidine<br>* INTRATHECAL AND INTRAVENOUS<br>* Other names: precidex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First request to analgesia | The first time the patient is asking for analgesia to control his pain | Postoperative up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative analgesia consumption | Total consumption of analgesia to control pain | Postoperative up to 24 hours | 
| visual analogue scale | The score subjectively measures the severity of pain and it is ranging from 0 when there is no pain to 10 when it is the worse pain imaginable | Every two hours for 24 hours postoperative |