Overview

This trial is active, not recruiting.

Condition postoperative pain
Treatments intrathecal magnesium sulphate,, intrathecal midazolam
Phase phase 2/phase 3
Sponsor Rangaraya Medical College
Start date January 2015
End date October 2015
Trial size 50 participants
Trial identifier NCT02619799, Rangaraya medical college

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Active Comparator)
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.
intrathecal magnesium sulphate, Magneon
comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
(Active Comparator)
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.
intrathecal midazolam Mizolam
comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine

Primary Outcomes

Measure
duration of postoperative analgesia
time frame: first 12 hours after completion of surgery.

Secondary Outcomes

Measure
quality 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..
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..
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..
quality 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.
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.
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.
Pulse rate
time frame: every 5 minute for initial 30 minutes,later every 5-10 minutes for first hour,then every 30 min intervals for first 12 postoperative hours.
systolic blood pressure
time frame: every 5 minute for initial 30 minutes,later every 5-10 minutes for first hour,then every 30 min intervals for first 12 postoperative hours.
diastolic blood presure
time frame: every 5 minute for initial 30 minutes,later every 5-10 minutes for first hour,then every 30 min intervals for first 12 postoperative hours.
perioperative side effects
time frame: through out the intraoperative period and first 12 postoperative hours.

Eligibility Criteria

Female participants from 18 years up to 28 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Rangaraya Medical College.