A Comparative Study of Intrathecal Magnesium Sulphate & Midazolam With Epidural Ropivacaine for Caesarean Patients
- Conditions
- Postoperative Pain
- Interventions
- Drug: intrathecal magnesium sulphate,
- Registration Number
- NCT02619799
- Lead Sponsor
- Rangaraya Medical College
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- 50 pregnant women
- ASA-I and II parturients
- Weight 50-80 kgs
- Pre-eclampsia
- Thrombocytopenia
- HELLP syndrome
- Parturients on magnesium therapy
- Foetal distress
- Parturients on benzodiazepine therapy
- Patient refusal
- Contraindications to regional anaesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GROUP A(MAGNESIUM GROUP) intrathecal magnesium sulphate, 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. GROUP B(MIDAZOLAM GROUP) Intrathecal midazolam 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.
- Primary Outcome Measures
Name Time Method Duration of Postoperative Analgesia first 12 hours after completion of surgery. pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.
- Secondary Outcome Measures
Name Time Method Onset of Sensory Blockade every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery.. the onset time of sensory blockade was assessed with pinprick .
Duration of Sensory Blockade every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery.. the duration of sensory blockade was assessed with pinprick .
Onset of Motor Blockade every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery. assessed with modified bromage scale.
Duration of Motor Blockade every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery. assessed with modified bromage scale.
Perioperative Side Effects through out the intraoperative period and first 12 postoperative hours. through out the intraoperative period and initial 12 hours postoperatively parturients were assessed for PONV,sedation,respiratory depression hypotension ,bradycardia and shivering.