Effect of Ketamine and Etomidate During RSI on Long Term Outcomes
NCT06179485 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1756
Last updated 2026-05-18
Summary
The RSI-LTO study collects long-term outcomes from the RSI trial (NCT05277896). One-third of adults who are intubated in the ED or ICU experience symptoms of posttraumatic stress disorder (PTSD). PTSD is a psychiatric disorder triggered by a "shocking, scary, or dangerous event." Critical illness, tracheal intubation, and mechanical ventilation can be traumatic and distressing events. Patients may recall the intubation procedure, the feeling of the breathing tube in their throat, or being unable to move ("paralyzed"). While on the breathing machine, patients may experience delirium, frightening hallucinations, and delusions. Patients with PTSD after critical illness can be hypervigilant, anxious, and troubled by intrusive thoughts, nightmares, and flashbacks that last months to years after critical illness and that PTSD negatively impacts patients' marriages, work, and quality of life and increases patients' risk of depression, anxiety, substance use disorder, and suicide. Ketamine may prevent PTSD symptoms by blocking the pathways in the brain's glutaminergic system that are responsible for the formation of traumatic memories In outpatients with chronic PTSD, a single dose of ketamine has been shown to reduce PTSD symptoms for up to 2 weeks. Even a modest reduction in PTSD would translate into tens of thousands of fewer cases of PTSD each year, more cases of PTSD each year than any other medical intervention evaluated to date.
Conditions
- Post-Traumatic Stress Disorder
- Acute Respiratory Failure
Interventions
- DRUG
-
The RSI-LTO study collects long-term outcomes from the RSI trial (NCT05277896). In the RSI trial, patients in the ketamine group will be assigned to receive intravenous ketamine for induction of anesthesia during tracheal intubation. A dose of 2 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). Treating clinicians will be able elect to give a lesser or greater dose of ketamine than recommended if felt to be required for optimal patient care.
- DRUG
-
Etomidate
The RSI-LTO study collects long-term outcomes from the RSI trial (NCT05277896). In the RSI trial, patients in the etomidate group will be assigned to receive intravenous etomidate for induction of anesthesia during tracheal intubation. A dose of 0.3 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). Treating clinicians will be able elect to give a lesser or greater dose of etomidate than recommended if felt to be required for optimal patient care.
Sponsors & Collaborators
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Vanderbilt University Medical Center
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-06
- Primary Completion
- 2027-01-31
- Completion
- 2028-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Propofol Versus Ketamine for Rapid Sequence Intubation in Critically Ill Patients
NCT05092152 ·Status: COMPLETED ·Phase: PHASE2
-
The Effects of Ketamine on Respiratory Stimulation and Transpulmonary Pressures
NCT01969227 ·Status: COMPLETED ·Phase: NA
-
Ketamine / Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial
NCT02105415 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Ketamine Infusion as Sedative Analgesic in Severe ARDS
NCT04818827 ·Status: COMPLETED
-
Drug Order for Rapid Sequence Intubation
NCT03420950 ·Status: COMPLETED ·Phase: NA
-
The Effect-site Concentration of Remifentanil Blunting Endotracheal Intubation Responses During Anesthesia Induction With Lidocaine or Sufentanil Combined With Etomidate: A Randomized Controlled Study
NCT07089173 ·Status: RECRUITING ·Phase: NA
-
The Effects of Lidocaine and Esmolol on Attenuation of Hemodynamic Response to Orotracheal Intubation
NCT03612492 ·Status: UNKNOWN ·Phase: PHASE4
-
Analgesia-First Sedation in Trauma Patients
NCT05751863 ·Status: RECRUITING ·Phase: NA
-
Ketamine Versus Propofol as ICU Sedation
NCT06243822 ·Status: COMPLETED ·Phase: PHASE4
-
Respiratory Depression During an Analgosedation Combining Remifentanil and Ketamine in TCI for Oocyte Retrieval
NCT03458143 ·Status: UNKNOWN
-
Remifentanil Requirement for Acceptable Intubating Condition
NCT02655380 ·Status: COMPLETED ·Phase: PHASE4
-
Use of Ketamine Associate With an Opioid for Sedation in ICU
NCT01560390 ·Status: COMPLETED ·Phase: PHASE4
-
Remifentanil and Atropine for Intubation in Neonates
NCT00815048 ·Status: COMPLETED ·Phase: PHASE4
-
Inhaled Nitrous Oxide for the Prevention of Emergence Reaction During Ketamine Administration in Adults, a Pilot Study
NCT02145169 ·Status: COMPLETED ·Phase: NA
-
Ketamine Sedation in Mechanically Ventilated Patients
NCT00122759 ·Status: UNKNOWN ·Phase: NA
-
Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Double-lumen Endobronchial Intubation
NCT02001285 ·Status: UNKNOWN ·Phase: NA
-
Combination Ketamine and Propofol vs Propofol for Emergency Department Sedation: A Prospective Randomized Trial
NCT01269307 ·Status: COMPLETED ·Phase: NA
-
Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy
NCT02305394 ·Status: UNKNOWN ·Phase: PHASE4
-
Ketamine-fentanyl VS Fentanyl for Analgosedation in SICU
NCT03879564 ·Status: COMPLETED ·Phase: PHASE4
-
Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome
NCT06014138 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl
NCT01825083 ·Status: WITHDRAWN ·Phase: NA
-
Ketamine Infusion and Hypoventilation
NCT01535976 ·Status: COMPLETED ·Phase: NA
-
The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation in Normotensive and Hypertensive Patients
NCT01880931 ·Status: COMPLETED ·Phase: NA
-
Comparison of Analgesic and Sedative Effects of Esmketamine and Remifentanil Combined With Propofol Respectively in Septic Shock Patients With Invasive Mechanical Ventilation
NCT05551910 ·Status: UNKNOWN ·Phase: NA
-
Optimal Remifentanil Ce for Preventing Severe Cough and Hyperdynamic Response During Tracheal Extubation
NCT03132519 ·Status: COMPLETED ·Phase: PHASE4