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Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery

Primary Purpose

Postspinal Hypotension, Cesarean Delivery, Norepinephrine

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Norepinephrine 5 mcg
Norepinephrine 10 mcg
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postspinal Hypotension

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • full-term singleton pregnant women
  • American society of anesthesiologist physical status of I or II,
  • scheduled for elective cesarean delivery

Exclusion Criteria:

  • Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
  • hypertensive disorders of pregnancy,
  • peripartum bleeding, coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or
  • any contraindication to regional anesthesia, and
  • baseline systolic blood pressure (SBP) < 100 mmHg

Sites / Locations

  • Kasr Alaini Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A

group B

Arm Description

Outcomes

Primary Outcome Measures

incidence of successful management of severe post-spinal hypotension
systolic blood pressure >80% of baseline within 2 min of drug injection

Secondary Outcome Measures

time to severe postspinal hypotension
minutes
incidence of reactive bradycardia
heart rate heart rate less than 55 beat per minute
incidence of reactive hypertension
systolic blood pressure >120% of baseline
incidence of nausea and vomiting
unpleasant painless subjective feeling that one will imminently vomit or vomiting
fetal umbilical blood pH
pH
baby Apgar score
score with 0, 1, or 2, depending on the observed condition.

Full Information

First Posted
February 22, 2022
Last Updated
June 15, 2023
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05290740
Brief Title
Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery
Official Title
Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Maternal hypotension after spinal block is a common complication after subarachnoid block in this population whose incidence reached 60% in many reports. Hypotension is associated with maternal and neonatal complications; therefore, it is highly recommended to use vasopressors, prophylactically and interactively, for prompt control maternal blood pressure. Despite the presence of various preventive regimens (fluid loading, maternal positioning, and vasopressors), many mothers develop intraoperative episodes of hypotension which requires the use of a vasopressor bolus. Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; and is increasingly used in obstetric anesthesia with acceptable maternal and neonatal outcomes. NE bolus could be used for rapid correction of maternal blood pressure in a dose which variedranged between 3.7-10 mcg. Till date, al the available data for the management of maternal hypotension did not differentiate between severe and non-severe hypotension. The incidence of severe maternal hypotension (systolic blood pressure ≤60% of baseline) ranged between 7-20%. In a recent report, Hassabelnaby et al compared 6 mcg and 10 mcg NE boluses in management of maternal hypotension and found that the doses had the same success rate (≈90%); however, most of the participants in the mentioned study had non-severe hypotension. Therefore, we hypothesize that severe hypotension should be separately investigated for the possible superiority of the higher over the lower dose of NE bolus. Insufficient NE bolus would lead to failed management and prolonged hypotensive episode, whereas a higher dose might lead to reactive hypertension and/or bradycardia, which is sometimes severe. Therefore, determining the optimum dose for NE bolus would enable proper control of maternal hemodynamic profile
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 Ringer's solution will be infused at rate of 15 mL/Kg 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. The decision to give prophylactic vasopressor infusion will be according to the attending anesthetist preferences. 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 or after 10 minutes from the last successfully managed hypotensive episode and before the delivery. . 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, NE bolus of 5 mcg will be given. Any other hypotensive episode (systolic blood pressure <80% of baseline) will be managed with NE bolus of 5 mcg. Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered. Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (0.5 IU) will be delivered over five seconds after delivery then infused at a rate of 2.5 IU/hour.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postspinal Hypotension, Cesarean Delivery, Norepinephrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Title
group B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Norepinephrine 5 mcg
Intervention Description
norepinephrine bolus of 5 mcg for treatment of sever postspinal hypotension
Intervention Type
Drug
Intervention Name(s)
Norepinephrine 10 mcg
Intervention Description
norepinephrine bolus of 10 mcg for treatment of sever postspinal hypotension
Primary Outcome Measure Information:
Title
incidence of successful management of severe post-spinal hypotension
Description
systolic blood pressure >80% of baseline within 2 min of drug injection
Time Frame
2 minutes after drug injection
Secondary Outcome Measure Information:
Title
time to severe postspinal hypotension
Description
minutes
Time Frame
1 minute after subarachnoid local anesthetic injection till 1 min after baby delivery
Title
incidence of reactive bradycardia
Description
heart rate heart rate less than 55 beat per minute
Time Frame
2 minutes after drug injection
Title
incidence of reactive hypertension
Description
systolic blood pressure >120% of baseline
Time Frame
2 minutes after drug injection
Title
incidence of nausea and vomiting
Description
unpleasant painless subjective feeling that one will imminently vomit or vomiting
Time Frame
1 minute after subarachnoid local anesthetic injection till 5 minute after baby delivery
Title
fetal umbilical blood pH
Description
pH
Time Frame
at 5 minutes post delivery
Title
baby Apgar score
Description
score with 0, 1, or 2, depending on the observed condition.
Time Frame
at 5 minutes post delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: full-term singleton pregnant women American society of anesthesiologist physical status of I or II, scheduled for elective cesarean delivery Exclusion Criteria: Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias), hypertensive disorders of pregnancy, peripartum bleeding, coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or any contraindication to regional anesthesia, and baseline systolic blood pressure (SBP) < 100 mmHg
Facility Information:
Facility Name
Kasr Alaini Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
protocol and data of this research could be available from the PI upon reasonable request

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Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery

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