Hypotension Clinical Trial
Official title:
Randomized Double-blinded Comparison of Norepinephrine and Phenylephrine in Bolus for Maintenance of Blood Pressure During Spinal Anesthesia for Cesarean Delivery
Verified date | April 2021 |
Source | Hospital dos Servidores do Estado do Rio de Janeiro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. Half of participants will receive bolus of phenylephrine while the other half will receive bolus of noradrenaline.
Status | Completed |
Enrollment | 72 |
Est. completion date | October 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pregnant women, with single gestation, with cesarean programming to be performed under spinal anesthesia; - Age above 18 years; - Physical State American Society of Anesthesiologists (ASA) II and III; - Weight between 50kg and 120kg; - Height between 140cm and 180cm. Exclusion Criteria: - Refusal to participate in the study; - Pregnant women with fetus with known abnormalities; - Pregnant women with cardiovascular disease; - Pregnant women with pregnancy-specific hypertensive disease; - Allergy to any medication to be used in the study; - Users of monoamine oxidase inhibitors; - Users of tricyclic antidepressants; - Emergency caesarean section due to acute fetal distress; - Situations in which the sensory level after single intrathecal injection of the local anesthetic does not reach at least T6 within 5 minutes after spinal anesthesia. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Federal Dos Servidores Do Estado | Rio De Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
Hospital dos Servidores do Estado do Rio de Janeiro |
Brazil,
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. — View Citation
Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of bolus required | Number of bolus doses of phenylephrine and noradrenaline to maintain systemic arterial pressure at 90% of baseline in pregnant women undergoing spinal anesthesia for cesarean | during the procedure | |
Primary | Heart rate | Number of episodes of heart rate under 60 bpm while using phenylephrine and noradrenaline in pregnant women undergoing spinal anesthesia for cesarean | during the procedure | |
Secondary | Neonatal gasometric outcome | To evaluate the neonatal outcome through the analysis of venous and arterial blood gases collected in the cord umbilical after birth. | during the procedure | |
Secondary | Neonatal Apgar outcome | To evaluate the neonatal outcome through the classification given by the neonatologist responsible for the care to the newborn in the delivery room with the use of the Apgar Scale (0-10), 10 the better classification. | during the procedure | |
Secondary | Nausea and vomiting | To evaluate the incidence of nausea and vomiting of the parturient during cesarean section | during the procedure |
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