Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512415
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
10 Vs15 mcg Norepinephrine Bolus in Severe Maternal Hypotension During Cesarean Delivery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing 10- Versus 15-mcg Norepinephrine Bolus for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Data regarding the optimum dose of norepinephrine for management of severe maternal hypotension is lacking A previous report showed that the use of 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension in addition the incidence of reactive bradycardia and hypertension was comparable in the two doses Therefore we hypothesize that using a higher dose of norepinephrine 15 mcg would increase the success rate of management of severe hypotensive episode
Detailed Description:
Upon arrival to the operating room the patient will be in supine position with left uterine displacement using a wedge below the right buttock Routine monitoring will be applied electrocardiography pulse oximetry and non-invasive blood pressure monitor An 18G-cannula will be inserted and the patients will receive 10 mg metoclopramide Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval
Lactated Ringers solution will be infused at rate of 15 mLKg over 10 minutes as a co-load spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle
After subarachnoid block mothers will be placed in the supine position with left-lateral tilt
Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic and will be confirmed if sensory block level is at T4
The patient would receive the study drug only if she developed severe post-spinal hypotension defined as systolic blood pressure 60 of the baseline reading as her first hypotensive episode The management of the hypotensive episode will be considered successful if the systolic blood pressure is 80 of the baseline within 2 mins of the bolus If the bolus failed norepinephrine bolus of 5 mcg will be given
Any other hypotensive episode systolic blood pressure 80 of baseline will be managed with norepinephrine bolus of 5 mcg
Intraoperative bradycardia defined as heart rate less than 55 bpm will be managed by IV atropine bolus 05 mg will be administered
Fluid administration will be continued up to a maximum of 15 liters An oxytocin bolus 1 IU will be delivered over five seconds after delivery then infused at a rate of 25-75 IUhour
Lactated Ringers solution will be infused at rate of 15 mLKg over 10 minutes as a co-load spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle
After subarachnoid block mothers will be placed in the supine position with left-lateral tilt
Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic and will be confirmed if sensory block level is at T4
The patient would receive the study drug only if she developed severe post-spinal hypotension defined as systolic blood pressure 60 of the baseline reading as her first hypotensive episode The management of the hypotensive episode will be considered successful if the systolic blood pressure is 80 of the baseline within 2 mins of the bolus If the bolus failed norepinephrine bolus of 5 mcg will be given
Any other hypotensive episode systolic blood pressure 80 of baseline will be managed with norepinephrine bolus of 5 mcg
Intraoperative bradycardia defined as heart rate less than 55 bpm will be managed by IV atropine bolus 05 mg will be administered
Fluid administration will be continued up to a maximum of 15 liters An oxytocin bolus 1 IU will be delivered over five seconds after delivery then infused at a rate of 25-75 IUhour
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None