Norepinephrine Addition in Spinal Anesthesia of Caesarean Section

NCT03626454 | Completed

• 1 other identifier: NASA2018
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to compare efficacy of prophylactic norepinephrine bolus versus Infusion in prevention of hypotension which occurs frequently after spinal anesthesia for caesarean section. The authors hypothesize that prophylactic norepinephrine bolus is as effective as infusion in Prevention of hypotension after spinal anesthesia in caesarean section

Conditions

Hypotension Drug-Induced

Keywords

Norepinephrine, hypotension, spinal, caesarean section

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  less than 80% baseline blood pressure

  5 to 15 minutes after giving spinal anesthesia

Secondary Outcomes (27)

• Baseline heart rate

  3 minutes before giving spinal anesthesia

• Baseline mean blood pressure

  3 minutes before giving spinal anesthesia

• Baseline systolic blood pressure

  3 minutes before giving spinal anesthesia

• Anesthesia to delivery time

  from immediately after giving anesthesia until delivery of fetus by surgeon

• Incision to delivery time

  in time of beginning of surgical incision of skin until delivery of fetus by surgeon

Other Outcomes (5)

• Age

  1 hour before operation once the patient recruited

• Weight

  1 hour before operation once the patient recruited

• Height

  1 hour before operation once the patient recruited

Study Arms (2)

group B

ACTIVE COMPARATOR

'Norepinephrine bolus' of 6 µg plus Normal Saline 0.9% Infusion Solution

Drug: Norepinephrine Bolus; Drug: Normal Saline 0.9% Infusion Solution

group I

ACTIVE COMPARATOR

'Norepinephrine infusion' 6 µg/kg/h plus 'Normal Saline Flush, 0.9% Injectable Solution

Drug: Norepinephrine infusion; Drug: Normal Saline Flush, 0.9% Injectable Solution

Interventions

Norepinephrine Bolus DRUG

'Norepinephrine Bitartarte' bolus of 6 µg/mL for 30 seconds immediately after intrathecal injection

Also known as: NORB

group B

Norepinephrine infusion DRUG

an infusion of 6 µg/mL norepinephrine that was started at 6 µg/kg/h immediately after intrathecal injection

Also known as: NORI

group I

Normal Saline Flush, 0.9% Injectable Solution DRUG

10 ml normal saline in syringe for bolus for 30 seconds immediately after intrathecal injection

Also known as: NORSB

group I

Normal Saline 0.9% Infusion Solution DRUG

50 ml syringe with normal saline infuse at a rate 1ml/kg/h immediately after intrathecal injection

Also known as: NORSI

group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• American Society of Anesthesiologists physical status classification II or III
• Elective caesarean section under spinal anesthesia
• Normal singleton pregnancy beyond 36 weeks gestation
• Weight 50-100 kg, height 150-180 cm

You may not qualify if:

• Patient refusal
• Allergy or hypersensitivity to norepinephrine
• Diabetes, excluding gestational diabetes
• Preexisting or pregnancy-induced hypertension
• Arrhythmia
• Cerebrovascular disease
• Known fetal abnormality or fetal distress
• Any contraindication to spinal anesthesia
• Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (6)

• Ngan Kee WD, Lee SWY, Ng FF, Khaw KS. Prophylactic Norepinephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery. Anesth Analg. 2018 Jun;126(6):1989-1994. doi: 10.1213/ANE.0000000000002243.

  PMID: 28678073 BACKGROUND

• Onwochei DN, Ngan Kee WD, Fung L, Downey K, Ye XY, Carvalho JCA. Norepinephrine Intermittent Intravenous Boluses to Prevent Hypotension During Spinal Anesthesia for Cesarean Delivery: A Sequential Allocation Dose-Finding Study. Anesth Analg. 2017 Jul;125(1):212-218. doi: 10.1213/ANE.0000000000001846.

  PMID: 28248702 BACKGROUND

• Ngan Kee WD, Khaw KS, Tan PE, Ng FF, Karmakar MK. Placental transfer and fetal metabolic effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery. Anesthesiology. 2009 Sep;111(3):506-12. doi: 10.1097/ALN.0b013e3181b160a3.

  PMID: 19672175 BACKGROUND

• Ngan Kee WD, Lee SW, Ng FF, Tan PE, Khaw KS. Randomized double-blinded comparison of norepinephrine and phenylephrine for maintenance of blood pressure during spinal anesthesia for cesarean delivery. Anesthesiology. 2015 Apr;122(4):736-45. doi: 10.1097/ALN.0000000000000601.

  PMID: 25635593 BACKGROUND

• Chen D, Qi X, Huang X, Xu Y, Qiu F, Yan Y, Li Y. Efficacy and Safety of Different Norepinephrine Regimens for Prevention of Spinal Hypotension in Cesarean Section: A Randomized Trial. Biomed Res Int. 2018 May 23;2018:2708175. doi: 10.1155/2018/2708175. eCollection 2018.

  PMID: 29951531 BACKGROUND

• Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. No abstract available.

  PMID: 25654435 BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hany M Yassin, M.D.

  Fayoum University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: An anesthesia resident who will not be involved with the conduct of the study will prepare and label the drug in the syringes according to the randomization codes. An investigator who will not be involved in subsequent patient care or assessment will open the topmost of 300 opaque sequentially numbered envelopes. One 50 ml and one 10 ml will be labeled as study drug and the 50 ml syringe will be connected to a syringe infusion pump. These two "study drug" syringes will be a part of double dummy technique to facilitate blindness. In group B, 50 ml syringe will contain saline, and 10 ml syringe will contain norepinephrine (.6 µg/ml). In group I, 50 ml syringe will contain norepinephrine (6 µg/ml) with, and 10 ml syringe will contain saline. Participant in both groups will receive bolus from 10 ml syringe over 30 seconds and infusion dose of 1 ml/kg/h simultaneously to expedite blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: October 16, 2020
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)