Comparison of Two Doses of Norepinephrine in Preventing Hypotension After Spinal Anesthesia

NCT03706755 | Completed Phase 4

• 1 other identifier: Norepinephrine
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the more effective intravenous bolus of norepinephrine for maintaining blood pressure during a spinal anesthesia for a cesarean delivery with the fewer side effects. Low blood pressure has been shown to decrease uterine perfusion and foetal outcomes during cesarean delivery under spinal anesthesia. For elective or semi-urgent cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and either sufentanil or fentanyl. This study plans to enroll 124 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Conditions

Anesthesia; Adverse Effect; Hypotension; Cesarean Section Complications; Vasopressor

Keywords

spinal anesthesia; blood pressure; norepinephrine; Cesarean Section

Outcome Measures

Primary Outcomes (4)

• systolic blood pressure variation before delivery

  difference between the baseline systolic blood pressure (SBP0) and the lowest systolic blood pressure (SBPmin) registred before delivery and computed as (SBP min -SBP0)/SBP0

  time from immediately after spinal anesthesia until delivery

• mean blood pressure variation before delivery

  difference between the baseline mean blood pressure(MBP0) and the lowest mean blood pressure (MBPmin) registred before delivery and computed as (MBP min -MBP0)/MBP0

  time from immediately after spinal anesthesia until delivery

• systolic blood pressure variation during cesarean delivery

  difference between the baseline systolic blood pressure (SBP0) and the lowest systolic blood pressure (SBPmin) registred during the cesarean section

  time from immediately after spinal anesthesia until the end of surgery

• mean blood pressure variation during cesarean delivery

  difference between the baseline mean blood pressure (MBP0) and the lowest systolic blood pressure (MBPmin) registred during the cesarean section

  time from immediately after spinal anesthesia until the end of surgery

Secondary Outcomes (12)

• Time to administartion of the first rescue bolus

  time from immediately after spinal anesthesia until delivery

• duration of hypotension

  immediately after spinal anesthesia until the end of surgery

• number of rescue boluses

  immediately after spinal anesthesia until the end of surgery

• Incidence of hypotension

  tile from right after spinal anesthesia until delivery

• Norepinephrine consumption

  time fro right after spinal anesthesia until the end of surgery

Study Arms (2)

A

ACTIVE COMPARATOR

group A: will receive 1 mcg/Kg of Norepinephrine intravenously

Drug: Norepinephrine: 1mcg/kg

B

ACTIVE COMPARATOR

group B: will receive 0.5 mcg/Kg of Norepinephrine intravenously

Drug: Norepinephrine 0,5mcg/kg

Interventions

Norepinephrine: 1mcg/kg DRUG

intervention:Parturients will receive Norepinephrine: a bolus of 1 mcg/Kg immediately after SA (preventive bolus) then they will receive complementary doses of Norepinephrine (half dose: 0.5 mcg/Kg) to maintain systolic blood pressure above 80 % of baseline

Also known as: Noraline, Noradrenaline

A

Norepinephrine 0,5mcg/kg DRUG

intervention: Parturients will receive Norepinephrine: a bolus of 0.5 mcg/Kg immediately after SA (preventive bolus) then they will receive complementary doses of Norepinephrine (half dose: 0.25 mcg/Kg) to maintain systolic blood pressure above 80 % of baseline

Also known as: Noraline, Noradrenaline

B

Eligibility Criteria

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

You may qualify if:

• Elective or semi-urgent CD under spinal anesthesia
• Age over 18 years
• Healthy singleton pregnancy beyond 36 weeks' gestation
• American Society of Anesthesiologists (ASA) physical status classification 2
• Weight 50 to 100 kg, and height 150 to 180 cm

You may not qualify if:

• Emergency CD red code ( extraction time \<15 min)
• Allergy or hypersensitivity to norepinephrine or sulfite
• Preexisting or pregnancy-induced hypertension, preeclampsia, eclampsia, the use of cardiac medication or medication for blood pressure control
• multiple gestation
• Cardiovascular or cerebrovascular disease
• Fetal abnormalities
• Suspicion of abnormal placentation
• History of diabetes mellitus (excluding gestational diabetes)
• Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
• documented history of postoperative nausea and vomiting, previous gastric bypass surgery, history of chronic opioid use (chronic pain syndrome)
• Patient refusal

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Tunis maternity and neonatology center, minisetry of public health

Tunis, 1007, Tunisia

Location

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• HAYEN Hayen maghrebi, professor

  University Tunis El Manar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical associate professor

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: May 3, 2018
• Primary Completion: September 2, 2018
• Study Completion: October 1, 2018
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

TU (1)