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The effect of bolus injection of phenylephrine and norepinephrine in preventing hypotension after spinal anesthesia in patients undergoing elective cesarean elective.

Comparison of bolus norepinephrine and phenylephrine for prophylaxis against post spinal anesthesia hypotension during elective caesarean delivery: A randomized controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080921001264N13
Enrollment
90
Registered
2023-01-31
Start date
2022-04-21
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications of anesthesia during the puerperium. Complications of anesthesia during the puerperium

Interventions

Intervention 1: Intervention group: NE norepinephrine group: 45 people: these people receive NE with a dose of 5 micrograms. Intervention 2: Control group: Phenylephrine PE group: 45 people: these peo

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: The participants in this study include pregnant women, 36 to 41 weeks, between 18 and 45 years old, who referred to Sayad Shirazi Hospital in Gorgan. These patients are candidates for elective Cesarean elective Do not have any restrictions for spinal anesthesia such as patient's lack of consent, sensitivity to anesthesia, injection site infection, and high intracerebral pressure. Patients who enter the study in case of failure of spinal anesthesia, unpredictable complications during surgery, such as bleeding during surgery more than normal for a cesarean section without problems (more than 1500 ml) and the sensory level of T4 is higher than are excluded from the study.

Exclusion criteria

Exclusion criteria: At the beginning of the study, patients with uncontrolled heart complications, high blood pressure disorders in pregnancy, diabetes, psychiatric and renal problems, systolic blood pressure less than 90 mm Hg, peripheral bleeding, coagulation disorders

Design outcomes

Primary

MeasureTime frame
In the first few minutes after the injection of both drugs, we expect an increase in blood pressure, and we also expect to maintain the heart rate after the use of norepinephrine. Timepoint: It was monitored every 2 minutes to 6 minutes, every 3 minutes to 15 minutes and every 5 minutes until the end of the surgery. Method of measurement: An increase in blood pressure was calculated as an increase in systolic pressure greater than 120% of baseline and a drop in blood pressure was calculated based on a decrease in systolic blood pressure below 80% of baseline.

Secondary

MeasureTime frame
Due to the short half-life of the drug, which is up to 3 minutes, and its metabolite is also inactive, we do not expect secondary effects. Timepoint: 5 minutes later. Method of measurement: In this study, an increase in blood pressure is calculated as an increase in systolic pressure more than 120% of the baseline, and a drop in blood pressure is calculated based on a decrease in systolic blood pressure below 80% of the baseline.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Erazbardi Ghorchaei

Gorgan University of Medical Sciences

ghourchaeiarazberdi@gmail.com+98 17 3245 1660

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026