Anesthesia Clinical Trial
Official title:
Comparison of Two Doses of Norepinephrine in Preventing Hypotension After Spinal Anesthesia for Cesarean Section
Verified date | October 2018 |
Source | University Tunis El Manar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 124 |
Est. completion date | October 1, 2018 |
Est. primary completion date | September 2, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Tunisia | Tunis maternity and neonatology center, minisetry of public health | Tunis |
Lead Sponsor | Collaborator |
---|---|
University Tunis El Manar |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to administartion of the first rescue bolus | timing of the first hypotension(defined as a decrease of SBP >20% of baseline and/or PAS<100mmHg) recsue bolus will be given at that moment | time from immediately after spinal anesthesia until delivery | |
Primary | systolic blood pressure variation | difference between the baseline systolic blood pressure (PAS0) and the lowest systolic blood pressure (PASmin) registred before delivery and computed as (PAS min -PAS0)/PAS0 | time from immediately after spinal anesthesia until delivery | |
Primary | mean blood pressure variation | difference between the baseline mean blood pressure(PAM0) and the lowest mean blood pressure (PAMmin) registred before delivery and computed as (PAM min -PAM0)/PAM0 | time from immediately after spinal anesthesia until delivery | |
Secondary | Incidence of hypotension | incidence of hypotension after the primary preventive bolus | tile from right after spinal anesthesia until delivery | |
Secondary | Norepinephrine consumption | Mean dose of Norepinephrine ( micrograms) given to maintain blood pressure between 80 and 100 % of baseline values after the primary preventive bolus | time fro right after spinal anesthesia until the end of surgery | |
Secondary | Nausea | Incidence of nausea. Measure will be done according to a simple scale: 0= no nausea; 1= nausea [Time | time of surgery (right after spinal anesthesia until end of surgery) | |
Secondary | Vomiting | incidence of Vomiting (V) during cesarean section with an infusion of a bolus Norepinephrine. Measure will be done according to a simple scale: 0= no vomiting; 1= vomiting | time of surgery (right after spinal anesthesia until end of surgery) | |
Secondary | arrhythmia | incidence of arrhythmic events during cesarean section with an infusion of a bolus of Norepinephrine | time of surgery (right after spinal anesthesia until end of surgery) | |
Secondary | Hypertension | a rise of systolic blood pressure (SBP)>20% of baseline or SBP>140mmHg | right after spinal anesthesia until end of surgery)] | |
Secondary | mean pH of the fetal cord blood | Fetal cord blood analysis will be done immediately after delivery in order to determine the pH value ( ie : logarithm of the blood concentration of hydrogen ions H+)in each group | time of birth | |
Secondary | Apgar score | apgar at 1 and 5 minutes Apgar at 1 and 5 minutes | at time of birth |
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