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
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring magnesium sulphate, intrathecal route, midazolam
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
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
NCT ID
NCT02619799
First Posted
November 19, 2015
Last Updated
February 12, 2016
Sponsor
Rangaraya Medical College
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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