Dr Ruth km pfau civil hospital karachi Dow University of health sciences, department of anesthesiology
Karachi, Sindh, 74200, Pakistan
Location status: Recruiting
Location contact
Rabia Kamal, FCPS Tainee
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06836986
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
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
Karachi, Sindh, 74200, Pakistan
Location status: Recruiting
Rabia Kamal, FCPS Tainee
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Arsalan Jamil, FCPS
CONTACT
Rabia Kamal, MBBS
CONTACT
Dow University of Health Sciences
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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