Menu
Recruiting NCT06836986

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

No phase Interventional Spinal Anesthesia Induced Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Norepinephrine Bolus, Phenylephrine bolus.
Who it may be relevant to
Registry conditions: Spinal Anesthesia Induced Hypotension. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Norepinephrine Bolus
    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.
  • Drug Phenylephrine bolus
    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.

Primary outcome measures

  • Incidence of spinal anesthesia induced Hypotension [Time frame: From induction of spinal anesthesia till delivery of neonate]

Eligibility criteria

Inclusion criteria

  • American society of anesthesiologists II and III patients
  • Age 18-40years
  • Gestational age 32 weeks and above

Exclusion criteria

  • Patients with hypertensive disorders of pregnancy having baseline systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 99 mmHg.
  • Baseline mean arterial pressure less than 70 mmHg.
  • Antepartum hemorrhage/intraoperative blood loss greater than 1000ml
  • history indicative of cardiovascular or neurological disease.
  • known fetal abnormality.
  • Patients taking serotonin reuptake inhibitor, Tricyclic antidepressants,monoamine oxidase inhibitors.
  • Maternal situations requiring immediate administration of general anesthesia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Pakistan · 1 center
  • Dr Ruth km pfau civil hospital karachi Dow University of health sciences, department of an — Karachi

Publications

  • 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. PMID 38633922
  • 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. PMID 15106218

Identifiers

NCT: NCT06836986 · spinal induced hypotension

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗