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

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Lead Sponsor:
University Tunis El Manar
Inclusion Criteria:

- 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

Exclusion Criteria:

- Emergency CD red code

- 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