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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group P | Active Comparator | Prophylactic bolus of phenylephrine will be administered right after spinal anesthesia induction |
|
| Group N | Experimental | Prophylactic bolus of norepinephrine will be administered right after spinal anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine Bolus | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of spinal anesthesia induced Hypotension | 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. | From induction of spinal anesthesia till delivery of neonate |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rabia Kamal, MBBS | Contact | 923342239607 | rabiakamal.ae@gmail.com | |
| Arsalan Jamil, FCPS | Contact | 923341226693 | 22arsalan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Ruth km pfau civil hospital karachi Dow University of health sciences, department of anesthesiology | Recruiting | Karachi | Sindh | 74200 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38633922 | Background | Nadella H, Islam A, Ina EA, Levin D, Bacoat-Jones T. The Management of Spinal and Epidural Anesthesia-Related Hypotension in the United States During Cesarean Childbirth. Cureus. 2024 Mar 17;16(3):e56340. doi: 10.7759/cureus.56340. eCollection 2024 Mar. | |
| 15106218 | Background | Ng K, Parsons J, Cyna AM, Middleton P. Spinal versus epidural anaesthesia for caesarean section. Cochrane Database Syst Rev. 2004;2004(2):CD003765. doi: 10.1002/14651858.CD003765.pub2. |
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participants confidentiality
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This study has two groups of participants. Group N and group P. Allocation of participants in each group is being done by basic randomization.
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both participants and investigator is unaware about the drug given. Data is being collected by the anesthesiologist who is not involved in this study.
| Phenylephrine bolus | Drug | 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. |
|