Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-31
Brief Title:
Continuous Infusion of Norepinephrine vs Phenylephrine During Spinal Anesthesia for Cesarean Section INPEACE
Sponsor:
Hassan II University
Organization:
Hassan II University
Study Overview
Official Title:
Manually Controlled Continuous Infusion of Norepinephrine vs Phenylephrine During Spinal Anesthesia for Cesarean Section A Double-blinded Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INPEACE
Brief Summary:
The goal of this clinical trial is to compare norepinephrine and ephedrine in maintaining blood pressure during spinal anaesthesia for elective cesarean delivery The main questions it aims to answer are
Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on neonatal outcome
Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on maternal hemodynamics Participants will receive either phenylephrine or norepinephrine infusion at the time of performing spinal anesthesia the infusion rate will be adjusted manually depending on maternal arterial pressure
Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on neonatal outcome
Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on maternal hemodynamics Participants will receive either phenylephrine or norepinephrine infusion at the time of performing spinal anesthesia the infusion rate will be adjusted manually depending on maternal arterial pressure
Detailed Description:
Its a randomized double-blind two-arm parallel non-inferiority controlled trial that will be conducted in Hassan II University Hospital Fes Morocco The aim of this study is to test the hypothesis that neonatal outcome as assessed by potential of hydrogen pH of umbilical artery is at least as good non-inferior when prophylactic continuous manually controlled infusion of norepinephrine NE is used to maintain blood pressure during spinal anaesthesia for elective cesarean delivery compared with the same infusion modalities of phenylephrine PHE with more stable blood pressure and less bradycardia
Before starting the study a simple randomization sequence will generate codes for two equal-sized groups One code for each patient will be placed into a sealed opaque sequentially numbered envelope by a research assistant who is not involved in patient management or data collection
Another person not involved in subsequent patient care or assessement either will open the envelope for each patient shortly before commencement of the study and prepared two identical 50-mL syringes according to the code contained in the envelops patients will be randomly allocated to receive PHE or NE infusion All the syringes were labelled as study drug To standardize and study the effects without affecting the potency of the drugs vasopressor doses were taken in an equipotent ratio 1251 for PHENE based on previous studies
The medication used in this study are
NE 4 ml vial of norepinephrine bitartrate injection 2 mgml
PHE 10 ml Phenylephrine hydrochloride pre-filled syringe 50 μgml In group PHE The infusion is prepared by taking 1 mg of phenylephrine 2 prefilled syringe equals to 20 ml and diluting it with 09 normal saline NS to attain a total volume of 40 mL and a concentration of 25 μgmL
In group NE Norepinephrine infusion will be prepared by taking one vial 8 mg of norepinephrine and diluting it with 496 ml of 09 normal saline NS to attain a concentration of NE of 16 µgml 10 ml of this solution Will be diluted in 09 NS to reach a total volume of 40 mL and a concentration of 4 μgmL of NE which correspond to 2 µgml of norepinephrine base
Eleven milligrams of hyperbaric bupivacaine in addition to 20 μg fentanyl will be injected in the L2-L3 L3-L4 or L4-L5 intervertebral space using a 25-gauge pencil-point spinal needle in the sitting position Block success will be assessed by sensory blockade level using pinprick test and surgery would not begin unless the sensory block reached T6 level Patients with inadequate sensory blockade would receive general anesthesia for cesarean delivery and will be excluded from the study
Simultaneously with the intrathecal injection rapid intravenous vascular volume expansion by 1000ml NS solution will be started with a pressure infuser bag inflated
The infusion will be initiated at a rate of 96 mLhour 16 mLminute that correspond to a phenylephrine rate infusion of 40 μgminute or norepinephrine rate infusion of 64 μgminute Both vasopressor infusions will be started at the same time that cerebrospinal fluid is obtained before the injection of the local anesthetic into the cerebrospinal fluid and then manually adjusted within the range 0-144 mLh PHE 0-60 μgmin NE 0-96 µgmin according to values of systolic blood pressure SBP measured noninvasively and recorded at 1-minute intervals along the intraoperative period with the objective of maintaining values near baseline according to this modalities table 1 Heart rate HR will be monitored continuously and recorded at 1-min interval
SBP of baseline Infusion rate mlmin NE delivery rate µgmin PHE delivery rate µgmin 120 or 140 mmhg 0 0 0 100-120 48 32 20 90-100 96 64 40 80-90 120 8 50 80 144 96 60
Table Algorithm of manually controlled infusion rate and its corresponding amount of study drug norepinephrine or phenylephrine depending on randomisation
A researcher in the theater will manage the infusions and collect the data for analysis Episodes of hypotension hypertension bradycardia and tachycardia will be recorded
Intraoperative hypertension defined as SBP greater than 120 of the baseline or 140 mmhg will be managed by stopping temporarily drug infusion The infusion is resumed when blood pressure return to 120 of the SBP baseline
Postspinal hypotension defined as decreased SBP less than 80 of the baseline or SBP 90 mmhg reading during the period from intrathecal injection to delivery of the fetus will be managed by increasing vasopressor infusion dose according to study protocol infusion above In case of persistant postspinal hypotension despite increasing vasopressor doses its will be managed by 2-ml bolus of the infusion which correspond for parturients with NE infusion to 8µg and those with PHE to 50 μg Additional vasopressor bolus will be given if SBP did not respond to the first dose within 2 min despite continuing the infusion
In case of persistence of hypotension A rescue bolus of at least ephedrine 6 mg is recommended and repeated according to the severity and persistence of the hypotension
After delivery and in the absence of hemorrhage the vasopressor flow rate will be reduced in steps of 20 mLh-1 while maintaining an SBP 80 of baseline a minimum delay of 5 minutes between 2 flow reductions is recommended to avoid secondary hypotension
Intraoperative bradycardia defined as heart rate less than 60 beats per minute without hypotension will be managed by stopping the vasopressor infusion
If bradycardia is associated with hypotension the patient will be managed by IV ephedrine 9 mg If bradycardia persist or decrease below 50 beatsmin after the previous measures an IV atropine bolus 05 mg should be given
Umbilical arterial blood UA will be sampled from a double-clamped segment of umbilical cord by using arterial blood gas syringes Within 20 min after clamping umbilical blood gas will be analyzed with a bedside Blood gas Analyzer System
Before starting the study a simple randomization sequence will generate codes for two equal-sized groups One code for each patient will be placed into a sealed opaque sequentially numbered envelope by a research assistant who is not involved in patient management or data collection
Another person not involved in subsequent patient care or assessement either will open the envelope for each patient shortly before commencement of the study and prepared two identical 50-mL syringes according to the code contained in the envelops patients will be randomly allocated to receive PHE or NE infusion All the syringes were labelled as study drug To standardize and study the effects without affecting the potency of the drugs vasopressor doses were taken in an equipotent ratio 1251 for PHENE based on previous studies
The medication used in this study are
NE 4 ml vial of norepinephrine bitartrate injection 2 mgml
PHE 10 ml Phenylephrine hydrochloride pre-filled syringe 50 μgml In group PHE The infusion is prepared by taking 1 mg of phenylephrine 2 prefilled syringe equals to 20 ml and diluting it with 09 normal saline NS to attain a total volume of 40 mL and a concentration of 25 μgmL
In group NE Norepinephrine infusion will be prepared by taking one vial 8 mg of norepinephrine and diluting it with 496 ml of 09 normal saline NS to attain a concentration of NE of 16 µgml 10 ml of this solution Will be diluted in 09 NS to reach a total volume of 40 mL and a concentration of 4 μgmL of NE which correspond to 2 µgml of norepinephrine base
Eleven milligrams of hyperbaric bupivacaine in addition to 20 μg fentanyl will be injected in the L2-L3 L3-L4 or L4-L5 intervertebral space using a 25-gauge pencil-point spinal needle in the sitting position Block success will be assessed by sensory blockade level using pinprick test and surgery would not begin unless the sensory block reached T6 level Patients with inadequate sensory blockade would receive general anesthesia for cesarean delivery and will be excluded from the study
Simultaneously with the intrathecal injection rapid intravenous vascular volume expansion by 1000ml NS solution will be started with a pressure infuser bag inflated
The infusion will be initiated at a rate of 96 mLhour 16 mLminute that correspond to a phenylephrine rate infusion of 40 μgminute or norepinephrine rate infusion of 64 μgminute Both vasopressor infusions will be started at the same time that cerebrospinal fluid is obtained before the injection of the local anesthetic into the cerebrospinal fluid and then manually adjusted within the range 0-144 mLh PHE 0-60 μgmin NE 0-96 µgmin according to values of systolic blood pressure SBP measured noninvasively and recorded at 1-minute intervals along the intraoperative period with the objective of maintaining values near baseline according to this modalities table 1 Heart rate HR will be monitored continuously and recorded at 1-min interval
SBP of baseline Infusion rate mlmin NE delivery rate µgmin PHE delivery rate µgmin 120 or 140 mmhg 0 0 0 100-120 48 32 20 90-100 96 64 40 80-90 120 8 50 80 144 96 60
Table Algorithm of manually controlled infusion rate and its corresponding amount of study drug norepinephrine or phenylephrine depending on randomisation
A researcher in the theater will manage the infusions and collect the data for analysis Episodes of hypotension hypertension bradycardia and tachycardia will be recorded
Intraoperative hypertension defined as SBP greater than 120 of the baseline or 140 mmhg will be managed by stopping temporarily drug infusion The infusion is resumed when blood pressure return to 120 of the SBP baseline
Postspinal hypotension defined as decreased SBP less than 80 of the baseline or SBP 90 mmhg reading during the period from intrathecal injection to delivery of the fetus will be managed by increasing vasopressor infusion dose according to study protocol infusion above In case of persistant postspinal hypotension despite increasing vasopressor doses its will be managed by 2-ml bolus of the infusion which correspond for parturients with NE infusion to 8µg and those with PHE to 50 μg Additional vasopressor bolus will be given if SBP did not respond to the first dose within 2 min despite continuing the infusion
In case of persistence of hypotension A rescue bolus of at least ephedrine 6 mg is recommended and repeated according to the severity and persistence of the hypotension
After delivery and in the absence of hemorrhage the vasopressor flow rate will be reduced in steps of 20 mLh-1 while maintaining an SBP 80 of baseline a minimum delay of 5 minutes between 2 flow reductions is recommended to avoid secondary hypotension
Intraoperative bradycardia defined as heart rate less than 60 beats per minute without hypotension will be managed by stopping the vasopressor infusion
If bradycardia is associated with hypotension the patient will be managed by IV ephedrine 9 mg If bradycardia persist or decrease below 50 beatsmin after the previous measures an IV atropine bolus 05 mg should be given
Umbilical arterial blood UA will be sampled from a double-clamped segment of umbilical cord by using arterial blood gas syringes Within 20 min after clamping umbilical blood gas will be analyzed with a bedside Blood gas Analyzer System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None