A Comparative Study of Intrathecal Magnesium Sulphate & Midazolam With Epidural Ropivacaine for Caesarean Patients

Study Overview
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Brief Summary
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This study compares whether addition of Magnesium or Midazolam intrathecally to epidurally administered isobaric Ropivacaine improves the quality of blockade, haemodynamics and duration of analgesia post-operatively. 25 parturients were given intrathecal Magnesium and rest of the 25 parturients were given intrathecal Midazolam combined with 0.75% Ropivacaine via epidural route.

Detailed Description
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Magnesium sulphate and Midazolam have been used in clinical trials as adjuvants to local anaesthetics via intrathecal and epidural routes and are effective in augmenting the quality of block and prolonging post-operative analgesia. Noxious stimulation leads to the release of glutamate and aspartate neuratransmitters which bind to various sub-classes of excitatory aminoacid, including the NMDA receptor. Intrathecal magnesium potentiates neuraxial anaesthesia by blocking NMDA receptors with out causing significant side effects as reported in various studies. Intrathecal Midazolam produces antinociception at spinal cord-level through benzodiazepine GABA-A receptor complex which are present abundantly in the lamina 2 of spinal cord. Midazolam also releases endogenous opioid acting at spinal delta receptors and also enhances adenosine release which also augments analgesia.

Official Title
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A Comparative Study Between Intrathecal Magnesium Sulphate Versus Midazolam Along With Epidural 0.75% Ropivacaine in Combined Spinal Epidural Technique for Preeclampsia Parturients Undergiong Elective Caesarean Section

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: intrathecal magnesium sulphate,
* Drug: Intrathecal midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 pregnant women ASA-I and II parturients Weight 50-80 kgs Pre-eclampsia Exclusion Criteria: Thrombocytopenia HELLP syndrome Parturients on magnesium therapy Foetal distress Parturients on benzodiazepine therapy Patient refusal Contraindications to regional anaesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROUP A(MAGNESIUM GROUP)<br>MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace. | Drug: intrathecal magnesium sulphate,<br>* comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine<br>* Other names: Magneon;|
| Active Comparator: GROUP B(MIDAZOLAM GROUP)<br>MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace. | Drug: Intrathecal midazolam<br>* comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine<br>* Other names: Mizolam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Postoperative Analgesia | pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours. | first 12 hours after completion of surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of Sensory Blockade | the onset time of sensory blockade was assessed with pinprick . | every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery.. | 
| Duration of Sensory Blockade | the duration of sensory blockade was assessed with pinprick . | every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery.. | 
| Onset of Motor Blockade | assessed with modified bromage scale. | every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery. | 
| Duration of Motor Blockade | assessed with modified bromage scale. | every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery. | 
| Perioperative Side Effects | through out the intraoperative period and initial 12 hours postoperatively parturients were assessed for PONV,sedation,respiratory depression hypotension ,bradycardia and shivering. | through out the intraoperative period and first 12 postoperative hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnesium sulphate, intrathecal route, midazolam