Different Noradrenaline Protocols in Post Spinal Hypotension in CS

NCT04701190 | Completed Phase 4

• 1 other identifier: 05
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of hypotension after spinal anesthesia is approximately 60% in parturients undergoing cesarean section. As a consequence of hypotension, nausea-vomiting, dyspnea and neurological deterioration in patients and low Apgar scores in newborns may occur. Therefore, there is an increasing interest to prevent maternal post spinal hypotension by using several drugs including noradrenaline given in different protocols to the patients undergoing spinal anesthesia for cesarean section. However, there is no conclusive answer to the question of which dosage is the best to prevent the maternal post spinal hypotension in literature. In this prospective randomized study, we aimed to compare different noradrenaline protocols for preventing maternal post spinal hypotension during elective cesarean delivery.

Conditions

Hypotension; Cesarean Section; Anesthesia, Spinal

Keywords

Apgar Score; Pregnancy; Blood Pressure; Heart Rate; adult; female; Hypotension; Noradrenaline; Cesarean Section; Anesthesia, Spinal

Outcome Measures

Primary Outcomes (2)

• Incidence of maternal post spinal hypotension

  The primary outcome of this study is to compare the incidences of maternal post spinal hypotension in patients administered three different noradrenaline protocols.

  Between the application time of spinal anesthesia and 5th minute after delivery

• Incidence of maternal post spinal severe hypotension

  The other primary outcome of this study is to compare the incidences of maternal post spinal severe hypotension in patients administered three different noradrenaline protocols.

  Between the application time of spinal anesthesia and 5th minute after delivery

Secondary Outcomes (3)

• The incidence of post delivery maternal hypotension

  Between 5th minute after delivery and the end of surgery

• The incidence of post delivery maternal severe hypotension

  Between 5 minute of delivery and the end of surgery

• The incidence of intervention applied by an anesthesiologist

  Between the start of patient monitoring and the end of surgery

Study Arms (3)

Noradrenaline 0.05/10

ACTIVE COMPARATOR

Study drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution. The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure. Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively. If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia. The noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.05 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus.

Drug: Noradrenalin 10 microgram bolus; Drug: Noradrenaline 0.05 microgram/kg/minute infusion; Procedure: Spinal anesthesia

Noradrenaline 0.075/5

ACTIVE COMPARATOR

Study drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution. The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure. Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively. If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia. The noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.075 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus.

Drug: Noradrenaline 5 microgram bolus; Drug: Infusion dosage: 0.075 microgram/kg/minute infusion; Procedure: Spinal anesthesia

Noradrenaline 0.1/0

ACTIVE COMPARATOR

Study drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution. The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure. Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively. If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.1 microgram/kg/minute without bolus dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus.

Drug: Noradrenaline 0.1 microgram/kg/minute infusion; Procedure: Spinal anesthesia

Interventions

Noradrenalin 10 microgram bolus DRUG

The noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.

Also known as: NA 10B

Noradrenaline 0.05/10

Noradrenaline 5 microgram bolus DRUG

The noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.

Also known as: NA 5B

Noradrenaline 0.075/5

Noradrenaline 0.1 microgram/kg/minute infusion DRUG

Infusion dosage: 0.1 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.1 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus.

Also known as: NA 0.1I

Noradrenaline 0.1/0

Noradrenaline 0.05 microgram/kg/minute infusion DRUG

Infusion dosage: 0.05 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.05 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus.

Also known as: NA 0.05I

Noradrenaline 0.05/10

Infusion dosage: 0.075 microgram/kg/minute infusion DRUG

nfusion dosage: 0.075 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.075 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus.

Also known as: NA 0.075I

Noradrenaline 0.075/5

Spinal anesthesia PROCEDURE

Spinal anesthesia using 0.5% 10 milligram heavy bupivacaine plus 12.5 microgram fentanyl

Noradrenaline 0.05/10; Noradrenaline 0.075/5; Noradrenaline 0.1/0

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Parturient
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 2
• +4 gestational age parturient

You may not qualify if:

• ASA 3-6
• Parturients with any kind of contraindication to spinal anesthesia
• Hypertensive parturients (basal systolic blood pressure above 140 mmHg)
• Parturients having basal systolic blood pressure below 100 mmHg
• Parturients having peripartum hemorrhage
• Parturients having body mass index above 40
• Parturients with a known allergic reaction to one of the study drugs
• Parturients not willing to be included into the study

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.

  PMID: 27720613 BACKGROUND

• Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.

  PMID: 30335625 BACKGROUND

• Hasanin A, Amin S, Refaat S, Habib S, Zayed M, Abdelwahab Y, Elsayad M, Mostafa M, Raafat H, Elshall A, Fatah SAE. Norepinephrine versus phenylephrine infusion for prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery: A randomised controlled trial. Anaesth Crit Care Pain Med. 2019 Dec;38(6):601-607. doi: 10.1016/j.accpm.2019.03.005. Epub 2019 Mar 30.

  PMID: 30935897 BACKGROUND

• Baytas V, Karadag Erkoc S, Ozcelik M, Gokmen D, Bermede AO, Selvi Can O, Uysalel A. A Randomized, Double-Blind, Graded Dose-Response Study of Norepinephrine Administration for Prevention of Post-Spinal Hypotension during Elective Cesarean Delivery. J Clin Med. 2023 Oct 10;12(20):6437. doi: 10.3390/jcm12206437.

  PMID: 37892573 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Menekse Ozcelik, M.D

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The hypotension will be recognized by the participants due to feeling unwell of theirselves. However they will not have any information about the dosage of the study drug. So they will be blinded to the study group which they will be included by the investigator of the study. The investigator will collect the data coming from the monitors, patients and the newborn. Therefore, the investigator will not be aware of the intervention about the dosing of noradrenaline made by the anesthesiologist.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: February 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)