Spinal Anesthesia Induced Hypotension
Conditions
Keywords
Spinal anesthesia induced hypotension, Emergency lower segment cesarean section, Norepinephrine bolus, Prophylactic, Phenylephrine
Brief summary
The goal of this clinical trial is to learn if norepinephrine is more effective than phenylephrine for prevention of spinal anesthesia induced hypotension. The main questions it aims to answer are: Does norepinephrine lower the incidence of spinal anesthesia induced hypotension in emergency obstetrical patients? We will compare effectiveness of norepinephrine and phenylephrine for the prevention of spinal anesthesia induced hypotension. Participants will: Be administered prophylactic boluses of both drugs right after spinal anesthesia induction and maternal hemodynamic parameters and neonatal APGAR scores will be recorded
Detailed description
Spinal anesthesia is a common mode of anesthesia in cesarean delivery. Spinal anesthesia induced hypotension is one of the most common complication that can affect both mother and fetus. For the management of spinal anesthesia induced hypotension, preloading with crystalloids and colloids, use on ionotropic agents and vasopressors have already been in practice. Objective of this study is to compare efficacy of prophylactic use of norepinephrine and phenylephrine bolus dosage for spinal anesthesia induced hypotension. This study is being conducted at the department of anesthesiology ,K.M Pfau civil hospital, Dow university of health sciences, Karachi , Pakistan. Data is being collected after taking approval from Institutional review board and written informed consent from the participants. Participants are being enrolled by primary investigator. All participants are undergoing simple randomization by lottery method. After enrollment of participants, demographic data, hemodynamic parameters and other relevant details are being recorded till delivery of the neonate. Hemodynamic parameters that are heart rate, systolic and diastolic blood pressure, mean arterial blood pressure is being recorded every 3mins. APGAR scoring of neonate is also being recorded. After completion of data collection, data will be done using Statistical package for social sciences 26.
Interventions
Prophylactic norepinephrine bolus of 8 micrograms will be administered right after spinal anesthesia induction. Rescue bolus of norepinephrine 4 micrograms will be administered in case of hypotension.
Prophylactic phenylephrine bolus of 100 micrograms will be administered right after spinal anesthesia induction. Rescue bolus of phenylephrine 50 micrograms will be administered in case of hypotension.
Sponsors
Dow University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
both participants and investigator is unaware about the drug given. Data is being collected by the anesthesiologist who is not involved in this study.
Intervention model description
This study has two groups of participants. Group N and group P. Allocation of participants in each group is being done by basic randomization.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of spinal anesthesia induced Hypotension | From induction of spinal anesthesia till delivery of neonate | Prophylactic norepinephrine and phenylephrine boluses will be administered to both groups right after spinal anesthesia induction.greater than 80% drop of the Systolic blood pressure will be defined as hypotension. |
Countries
Pakistan
Contacts
Primary ContactRabia Kamal, MBBS
Backup ContactArsalan Jamil, FCPS
Outcome results
None listed