Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A(MAGNESIUM GROUP) | 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. |
|
| GROUP B(MIDAZOLAM GROUP) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrathecal magnesium sulphate, | Drug | comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Postoperative Analgesia | pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours. | first 12 hours after completion of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of Sensory Blockade | the onset time of sensory blockade was assessed with pinprick . | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10960384 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | parturients aged between 18-28 years were included in the study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Postoperative Analgesia | pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours. | Posted | Mean | Standard Deviation | time in minutes | first 12 hours after completion of surgery. |
|
first 12 hours of postoperative period all the parturients were monitored for any adverse events like nausea,vomiting,shivering,respiratory depression and sedation.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| shivering | Surgical and medical procedures | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Paleti Sophia | Rangaraya medical college | 9948599758 ,08842343023 | dr.sophia29@gmail.com |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Intrathecal midazolam | Drug | comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine |
|
|
the duration of sensory blockade was assessed with pinprick .
| every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery.. |
| Onset of Motor Blockade | assessed with modified bromage scale. | 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 | assessed with modified bromage scale. | every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery. |
| 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. | through out the intraoperative period and first 12 postoperative hours. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | female parturients who completed 37 weeks of gestational age and who are preeclamptic were included in the study | Number | participants |
|
| weight in kilograms | parturients weighing between 50 -80 kilograms were included in the study | Mean | Standard Deviation | kilograms |
|
| age in years | Mean | Standard Deviation | years |
|
| height in centimeters | Parturients with height range between 150-170 cms were included in the study | Mean | Standard Deviation | centimeters |
|
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
|
|
| Secondary | Onset of Sensory Blockade | the onset time of sensory blockade was assessed with pinprick . | Posted | Mean | Standard Deviation | time in minutes | every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery.. |
|
|
|
| Secondary | Duration of Sensory Blockade | the duration of sensory blockade was assessed with pinprick . | Posted | Mean | Standard Deviation | time in minutes | every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery.. |
|
|
|
| Secondary | Onset of Motor Blockade | assessed with modified bromage scale. | Posted | Mean | Standard Deviation | time in minutes | every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery. |
|
|
|
| Secondary | Duration of Motor Blockade | assessed with modified bromage scale. | Posted | Mean | Standard Deviation | time in minutes | every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery. |
|
|
|
| Secondary | 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. | Posted | Number | participants | through out the intraoperative period and first 12 postoperative hours. |
|
|
|
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | 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 | 0 | 25 | 3 | 25 |
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |