Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564857
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-25
Brief Title:
Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation in Patients Undergoing General Anaesthesia - a Multicentre Randomised Controlled Trial -The ROCVIDEO Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROCVIDEO
Brief Summary:
Globally we are approaching 1 million surgical procedures each day Tracheal intubation is the mainstay of securing the patients airway and breathing during general anaesthesia Approximately 100000 tracheal intubations are performed annually in Denmark Airway management remains the primary reason for anaesthesia-related morbidity and mortality It has been traditionally accepted that best tracheal intubation conditions are obtained by paralysing the patients muscles including vocal cords using a neuromuscular blocking agent NMBA such as rocuronium However using NBMA may increase the risk of pulmonary complications intra-operative awareness in which the patient is paralysed but awake during surgery anaphylaxis and re-intubation In addition there is a risk of residual neuromuscular blockade postoperatively In the US prolonged ventilation and unplanned intubation are the top two most costly perioperative complications An alternative to NMBA is a large dose of opioids to depress laryngeal reflexes during intubation The most commonly used non-NMBA modality includes bolus administration of remifentanil However remifentanil may cause bradycardia and hypotension Even short periods of hypotension have been shown to increase the risk of myocardial injury and other serious adverse events such as renal failure delirium and even mortality
Evidence also indicates that intubation conditions using only opioids to facilitate intubation including remifentanil are inferior to NMBA However these trials are underpowered to assess effects on patient-important outcomes and are mostly at high risk of bias A recent trial has suggested that remifentanil intubation conditions may not be very different Almost all existing research comparing NMBA to opioids has focused on intubation conditions for direct laryngoscopy using a conventional Macintosh laryngoscopy blade In recent years the implementation and availability of the video laryngoscope have grown exponentially and become universal The video laryngoscope has vastly improved the ease of tracheal intubation and the number of failed intubations has decreased by two-thirds in Denmark where a rapid implementation of the video laryngoscope took place However limited evidence exists on whether NMBA improves intubation conditions compared to remifentanil when performing video laryngoscope-assisted tracheal intubation
Evidence also indicates that intubation conditions using only opioids to facilitate intubation including remifentanil are inferior to NMBA However these trials are underpowered to assess effects on patient-important outcomes and are mostly at high risk of bias A recent trial has suggested that remifentanil intubation conditions may not be very different Almost all existing research comparing NMBA to opioids has focused on intubation conditions for direct laryngoscopy using a conventional Macintosh laryngoscopy blade In recent years the implementation and availability of the video laryngoscope have grown exponentially and become universal The video laryngoscope has vastly improved the ease of tracheal intubation and the number of failed intubations has decreased by two-thirds in Denmark where a rapid implementation of the video laryngoscope took place However limited evidence exists on whether NMBA improves intubation conditions compared to remifentanil when performing video laryngoscope-assisted tracheal intubation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None