Comparing norepinephrine and phenylephrine to prevent low blood pressure during spinal anesthesia in emergency cesarean sections
COMPARISON BETWEEN EFFICACY OF NOREPINEPHRINE AND PHENYLEPHRINE BOLUSES FOR PREVENTION OF SPINAL ANAESTHESIA INDUCED HYPOTENSION IN OBSTETRICAL PATIENTS UNDERGOING EMERGENCY CESAREAN SECTION- A Double Blind Randomized Controlled Trial
This study is testing whether norepinephrine works better than phenylephrine to prevent low blood pressure in pregnant women having emergency cesarean sections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Dow University of Health Sciences Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT06836986 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether norepinephrine is more effective than phenylephrine in preventing spinal anesthesia induced hypotension in obstetrical patients undergoing emergency cesarean sections. Participants will receive prophylactic boluses of both medications immediately after spinal anesthesia induction, and their hemodynamic parameters and neonatal APGAR scores will be monitored. The study is conducted at the K.M. Pfau Civil Hospital in Karachi, Pakistan, with data collected following ethical approval and informed consent. Randomization of participants will be performed using a lottery method to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are obstetrical patients aged 18-40 years, classified as ASA II and III, with a gestational age of 32 weeks or more.
Not a fit: Patients with hypertensive disorders of pregnancy, significant cardiovascular or neurological diseases, or those requiring immediate general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of spinal anesthesia induced hypotension, enhancing maternal and neonatal outcomes during emergency cesarean sections.
How similar studies have performed: While the use of vasopressors in managing spinal anesthesia induced hypotension is established, this specific comparison of norepinephrine and phenylephrine is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. American society of anesthesiologists II and III patients 2. Age 18-40years 3. Gestational age 32 weeks and above Exclusion Criteria: 1. Patients with hypertensive disorders of pregnancy having baseline systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 99 mmHg. 2. Baseline mean arterial pressure less than 70 mmHg. 3. Antepartum hemorrhage/intraoperative blood loss greater than 1000ml 4. history indicative of cardiovascular or neurological disease. 5. known fetal abnormality. 6. Patients taking serotonin reuptake inhibitor, Tricyclic antidepressants,monoamine oxidase inhibitors. 7. Maternal situations requiring immediate administration of general anesthesia
Where this trial is running
Karachi, Sindh
- Dr Ruth km pfau civil hospital karachi Dow University of health sciences, department of anesthesiology — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Study coordinator: Rabia Kamal, MBBS
- Email: rabiakamal.ae@gmail.com
- Phone: 923342239607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.