Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

Study Overview
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Brief Summary
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The aim of this work is to compare the hemodynamic and analgesic properties of Dexmedetomidine and Magnesium sulphate infusion in lower abdominal surgery.

Detailed Description
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Dexmedetomidine is a relatively new alpha 2 adrenergic receptor agonist with a higher α2/α1 selectivity ratio of 1620:1 that provides analgesic and anesthetic effects . Dexmedetomidine has various clinical uses in anesthesia such as sedation, and prolongation of the duration of postoperative analgesia when used as an adjuvant through intrathecal, epidural, or intravenous routes. Magnesium sulphate is another commonly used drug in anesthesia. Magnesium sulphate suppresses nociceptive impulses through inhibition of voltage-gated calcium channels and through antagonism of the N-methyl D-aspartate (NMDA) receptors. Although both drugs were reported to prolong the duration of spinal anesthesia, no studies to the best of our knowledge had compared the analgesic and hemodynamic profile of both drugs when used as intravenously during spinal anesthesia.

Official Title
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Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia for Lower Abdominal Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Magnesium Sulphate
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients aged between 18 and 65 years. Scheduled for lower abdominal surgery. Exclusion Criteria: Systolic blood pressure less than 100 mmHg Coagulation disorders History of heart failure Mitral or Aortic stenosis

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine group<br>This group will receive dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour | Drug: Dexmedetomidine<br>* This group will receive Dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour.<br>* Other names: Precedex;|
| Active Comparator: Magnesium Sulphate group<br>This group will receive Magnesium Sulphate infusion at a rate of 15 mg/Kg/hour | Drug: Magnesium Sulphate<br>* This group will receive Magnesium sulphate infusion at a rate of 15 mg/Kg/hour<br>|
| Placebo Comparator: Saline group<br>This group will receive normal saline infusion | Drug: Normal saline<br>* This group will receive normal saline infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesia | Duration of analgesia after the operation defined as the time till the first analgesic request by the patient | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Systolic blood pressure measured in mmHg | 6 hours | 
| Diastolic blood pressure | Diastolic blood pressure measured in mmHg | 6 hours | 
| Heart rate | The number of heart beats per minute | 6 hours | 
| Onset of sensory block | The time needed to have complete sensory block after spinal anesthesia measured in minutes | 30 minutes after spinal anesthesia | 
| Onset of motor block | The time needed to have complete motor block after spinal anesthesia measured in minutes | 30 minutes after spinal anesthesia | 
| Duration of motor block | The time needed for recovery of motor motor after spinal anesthesia measured in hours | 12 hours | 
| Ramsay Sedation Scale | A scale used for assessment of sedation level ranges from 1 (combative) to 6 (unarousable) | 12 hours after spinal anesthesia |