Trial Outcomes & Findings for A Comparative Study of Intrathecal Magnesium Sulphate & Midazolam With Epidural Ropivacaine for Caesarean Patients (NCT NCT02619799)
NCT ID: NCT02619799
Last Updated: 2016-03-14
Results Overview
pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
50 participants
Primary outcome timeframe
first 12 hours after completion of surgery.
Results posted on
2016-03-14
Participant Flow
Participant milestones
| Measure |
GROUP A(MAGNESIUM GROUP)
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,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
GROUP B(MIDAZOLAM GROUP)
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: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparative Study of Intrathecal Magnesium Sulphate & Midazolam With Epidural Ropivacaine for Caesarean Patients
Baseline characteristics by cohort
| Measure |
GROUP A(MAGNESIUM GROUP)
n=25 Participants
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,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
GROUP B(MIDAZOLAM GROUP)
n=25 Participants
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: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
50 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex/Gender, Customized
female pregnant patients
|
25 participants
n=39 Participants
|
25 participants
n=41 Participants
|
50 participants
n=35 Participants
|
|
weight in kilograms
|
68 kilograms
STANDARD_DEVIATION 5 • n=39 Participants
|
72 kilograms
STANDARD_DEVIATION 6 • n=41 Participants
|
70 kilograms
STANDARD_DEVIATION 5.5 • n=35 Participants
|
|
age in years
|
23 years
STANDARD_DEVIATION 2 • n=39 Participants
|
26 years
STANDARD_DEVIATION 3 • n=41 Participants
|
24.5 years
STANDARD_DEVIATION 2.5 • n=35 Participants
|
|
height in centimeters
|
156 centimeters
STANDARD_DEVIATION 3 • n=39 Participants
|
158 centimeters
STANDARD_DEVIATION 6 • n=41 Participants
|
157 centimeters
STANDARD_DEVIATION 4.5 • n=35 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
GROUP A(MAGNESIUM GROUP)
n=25 Participants
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,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
GROUP B(MIDAZOLAM GROUP)
n=25 Participants
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: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
|---|---|---|
|
Duration of Postoperative Analgesia
|
334 time in minutes
Standard Deviation 39
|
280 time in minutes
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: 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 .
Outcome measures
| Measure |
GROUP A(MAGNESIUM GROUP)
n=25 Participants
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,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
GROUP B(MIDAZOLAM GROUP)
n=25 Participants
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: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
|---|---|---|
|
Onset of Sensory Blockade
|
9.86 time in minutes
Standard Deviation 1.37
|
7.93 time in minutes
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 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 .
Outcome measures
| Measure |
GROUP A(MAGNESIUM GROUP)
n=25 Participants
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,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
GROUP B(MIDAZOLAM GROUP)
n=25 Participants
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: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
|---|---|---|
|
Duration of Sensory Blockade
|
295 time in minutes
Standard Deviation 36
|
245 time in minutes
Standard Deviation 26.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
GROUP A(MAGNESIUM GROUP)
n=25 Participants
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,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
GROUP B(MIDAZOLAM GROUP)
n=25 Participants
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: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
|---|---|---|
|
Onset of Motor Blockade
|
12.5 time in minutes
Standard Deviation 1.6
|
7.68 time in minutes
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
GROUP A(MAGNESIUM GROUP)
n=25 Participants
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,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
GROUP B(MIDAZOLAM GROUP)
n=25 Participants
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: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
|---|---|---|
|
Duration of Motor Blockade
|
265 time in minutes
Standard Deviation 24.6
|
223 time in minutes
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
GROUP A(MAGNESIUM GROUP)
n=25 Participants
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,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
GROUP B(MIDAZOLAM GROUP)
n=25 Participants
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: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
|---|---|---|
|
Perioperative Side Effects
Nausea and vomiting
|
2 participants
|
3 participants
|
|
Perioperative Side Effects
shivering
|
1 participants
|
3 participants
|
Adverse Events
GROUP A(MAGNESIUM GROUP)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GROUP B(MIDAZOLAM GROUP)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GROUP A(MAGNESIUM GROUP)
n=25 participants at risk
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,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
GROUP B(MIDAZOLAM GROUP)
n=25 participants at risk
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: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
|
|---|---|---|
|
Surgical and medical procedures
shivering
|
4.0%
1/25 • Number of events 2 • first 12 hours of postoperative period all the parturients were monitored for any adverse events like nausea,vomiting,shivering,respiratory depression and sedation.
|
12.0%
3/25 • Number of events 6 • first 12 hours of postoperative period all the parturients were monitored for any adverse events like nausea,vomiting,shivering,respiratory depression and sedation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place