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

Rangaraya Medical College

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Intrathecal midazolam; Drug: intrathecal magnesium sulphate,

Study type: Interventional

Funder types: Other

Identifiers

NCT02619799

Rangaraya medical college

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 28 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

GROUP A(MAGNESIUM GROUP)

Active Comparator group

Description:

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.

Treatment:

Drug: intrathecal magnesium sulphate,

GROUP B(MIDAZOLAM GROUP)

Active Comparator group

Description:

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.

Treatment:

Drug: Intrathecal midazolam