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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
intrathecal magnesium sulphate,
Intrathecal midazolam
Sponsored by
Rangaraya Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring magnesium sulphate, intrathecal route, midazolam

Eligibility Criteria

18 Years - 28 Years (Adult)FemaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    GROUP A(MAGNESIUM GROUP)

    GROUP B(MIDAZOLAM GROUP)

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Duration of Postoperative Analgesia
    pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.

    Secondary Outcome Measures

    Onset of Sensory Blockade
    the onset time of sensory blockade was assessed with pinprick .
    Duration of Sensory Blockade
    the duration of sensory blockade was assessed with pinprick .
    Onset of Motor Blockade
    assessed with modified bromage scale.
    Duration of Motor Blockade
    assessed with modified bromage scale.
    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.

    Full Information

    First Posted
    November 19, 2015
    Last Updated
    February 12, 2016
    Sponsor
    Rangaraya Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02619799
    Brief Title
    A Comparative Study of Intrathecal Magnesium Sulphate & Midazolam With Epidural Ropivacaine for Caesarean Patients
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rangaraya Medical College

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    magnesium sulphate, intrathecal route, midazolam

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GROUP A(MAGNESIUM GROUP)
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    GROUP B(MIDAZOLAM GROUP)
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    intrathecal magnesium sulphate,
    Other Intervention Name(s)
    Magneon
    Intervention Description
    comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    Intrathecal midazolam
    Other Intervention Name(s)
    Mizolam
    Intervention Description
    comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
    Primary Outcome Measure Information:
    Title
    Duration of Postoperative Analgesia
    Description
    pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.
    Time Frame
    first 12 hours after completion of surgery.
    Secondary Outcome Measure Information:
    Title
    Onset of Sensory Blockade
    Description
    the onset time of sensory blockade was assessed with pinprick .
    Time Frame
    every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..
    Title
    Duration of Sensory Blockade
    Description
    the duration of sensory blockade was assessed with pinprick .
    Time Frame
    every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..
    Title
    Onset of Motor Blockade
    Description
    assessed with modified bromage scale.
    Time Frame
    every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.
    Title
    Duration of Motor Blockade
    Description
    assessed with modified bromage scale.
    Time Frame
    every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.
    Title
    Perioperative Side Effects
    Description
    through out the intraoperative period and initial 12 hours postoperatively parturients were assessed for PONV,sedation,respiratory depression hypotension ,bradycardia and shivering.
    Time Frame
    through out the intraoperative period and first 12 postoperative hours.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    28 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    10960384
    Citation
    Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA. Advantages of intrathecal nalbuphine, compared with intrathecal morphine, after cesarean delivery: an evaluation of postoperative analgesia and adverse effects. Anesth Analg. 2000 Sep;91(3):601-5. doi: 10.1097/00000539-200009000-00019.
    Results Reference
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    A Comparative Study of Intrathecal Magnesium Sulphate & Midazolam With Epidural Ropivacaine for Caesarean Patients

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