COMPARING EFFECTIVENESS OF INTRAVENOUS EPHEDRINE BOLUS AND NOREPINEPHRINE INFUSION FOR MANAGING PERI INTUBATION LOW BLOOD PRESSURE IN CRITICALLY ILL ADULTS UNDERGOING ENDOTRACHEAL INTUBATION IN THE INTENSIVE CARE UNITS.

COMPARING EFFECTIVENESS OF INTRAVENOUS EPHEDRINE BOLUS AND NOREPINEPHRINE INFUSION FOR MANAGING PERI INTUBATION HYPOTENSION IN CRITICALLY ILL ADULTS UNDERGOING ENDOTRACHEAL INTUBATION IN THE INTENSIVE CARE UNITS: A PROSPECTIVE OPEN LABEL RANDOMISED CONTROLLED TRIAL. - The PREVENT PIH Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/107163

Enrollment

198

Registered

2026-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: COMPARING EFFECTIVENESS OF INTRAVENOUS EPHEDRINE BOLUS. Agent Intravenous Ephedrine bolus.: Agent Intravenous Ephedrine bolus. Dose 6 mg IV bolus, repeatable up to a maximum of 24

Eligibility

Inclusion criteria

Inclusion criteria: Critically ill adults above 18 years Requiring emergency endotracheal intubation in the ICU or ED.

Exclusion criteria

Exclusion criteria: Known arrhythmia requiring antiarrhythmics. Pregnancy. Allergy to study drugs. Patient who are already on vasopressor support.

Design outcomes

Primary

Measure	Time frame
Incidence of Peri-Intubation Hypotension PIH as either a systolic blood pressure SBP less than 90 mmHg or a mean arterial pressure MAP less than 65 mmHg occurring within a predefined time window 10 min following induction.Timepoint: Incidence of Peri-Intubation Hypotension PIH as either a systolic blood pressure SBP less than 90 mmHg or a mean arterial pressure MAP less than 65 mmHg occurring within a predefined time window 10 min following induction.	—

Measure

Time frame

Incidence of Peri-Intubation Hypotension PIH as either a systolic blood pressure SBP less than 90 mmHg or a mean arterial pressure MAP less than 65 mmHg occurring within a predefined time window 10 min following induction.Timepoint: Incidence of Peri-Intubation Hypotension PIH as either a systolic blood pressure SBP less than 90 mmHg or a mean arterial pressure MAP less than 65 mmHg occurring within a predefined time window 10 min following induction.

—

Secondary

Measure	Time frame
1 Maximum heart rate recorded within 10 minutes post intubation to assess the chronotropic effects of each agent. 2 Requirement for rescue vasopressor bolus or initiation of vasopressor infusion within 10 minutes post induction. 3 Time to hemodynamic recovery defined as achieving maintaining MAP more than equal to 65 mmHg for at least two consecutive readings. 4 Occurrence of cardiac arrest or clinically significant arrhythmia within one hour of intubation. 5 Change in SOFA score or development of new organ dysfunction within 48 hours post intubation. 6 30 day all cause mortality.Timepoint: Maximum heart rate at 10 min post intubation Rescue vasopressor requirement at 10 min post induction Hemodynamic recovery MAP greater than or equal to 65 mmHg within 60 min post intubation Cardiac arrest or arrhythmia within 1 hour post intubation SOFA score change or new organ dysfunction at 24 hourand 48 hour post intubation. All cause mortality at 30 days	—

Measure

Time frame

1 Maximum heart rate recorded within 10 minutes post intubation to assess the chronotropic effects of each agent. 2 Requirement for rescue vasopressor bolus or initiation of vasopressor infusion within 10 minutes post induction. 3 Time to hemodynamic recovery defined as achieving maintaining MAP more than equal to 65 mmHg for at least two consecutive readings. 4 Occurrence of cardiac arrest or clinically significant arrhythmia within one hour of intubation. 5 Change in SOFA score or development of new organ dysfunction within 48 hours post intubation. 6 30 day all cause mortality.Timepoint: Maximum heart rate at 10 min post intubation Rescue vasopressor requirement at 10 min post induction Hemodynamic recovery MAP greater than or equal to 65 mmHg within 60 min post intubation Cardiac arrest or arrhythmia within 1 hour post intubation SOFA score change or new organ dysfunction at 24 hourand 48 hour post intubation. All cause mortality at 30 days

—

Countries

India

Contacts

Public Contactsamir samal

IMS AND SUM HOSPITAL BHUBANESWAR

sachindevgude@gmail.com9284768698

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026