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

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Tunis El Manar
• Treatments: Anesthetics; Norepinephrine

Criteria

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