Skip to main content
OpenTrials
Completed

NCT Number: NCT02619799

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–28 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intrathecal magnesium sulphate,

Drug

comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine

Other names: Magneon

Intrathecal midazolam

Drug

comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine

Other names: Mizolam

Primary outcomes

  1. Duration of Postoperative Analgesia

    Time frame: 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 outcomes

  1. Onset of Sensory Blockade

    Time frame: 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 .

  2. Duration of Sensory Blockade

    Time frame: 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 .

  3. Onset of Motor Blockade

    Time frame: 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.

  4. Duration of Motor Blockade

    Time frame: 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.

  5. Perioperative Side Effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rangaraya Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2015
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.