NCT04868409

Intubating Conditions During Rapid Sequence Induction in Elderly With Either Suxamethonium 1.0 mg/kg or Rocuronium 1.0 mg/kg

A Single Blinded Multicenter Randomized Study Comparing Intubating Conditions During Rapid Sequence Induction With Either Suxamethonium 1.0 mg/kg or Rocuronium 1.0 mg/kg in Elderly Patients (≥ 80 Years Old)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Matias Vested · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine the proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years during rapid sequence induction.

Detailed description

Elderly patients are frail and susceptible to complications in the perioperative period. They are at higher risk of major morbidity and mortality and are characterized by a reduction in cardiac output, liver function and renal function. These physiological changes influence pharmacodynamics and pharmacokinetics of drugs administered during anesthesia as for example neuromuscular blocking agents (NMBA). The number of elderly patients (\>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia with employment of rapid sequence induction (RSI) within the next decades. RSI and intubation is performed when there is an increased risk of pulmonary aspiration of gastric contents. Because of its fast onset time succinylcholine is often used to facilitate tracheal intubation during RSI. However, succinylcholine has certain side effects such as cardiac arrhythmia, hyperkalemia, muscle soreness, short duration of action and shorter time to desaturation. It is therefore unknown if succinylcholine 1.0 mg/kg provides better intubating conditions compared to high dose rocuronium (1.0 mg/kg) in the elderly. In this matter, there remains a need for a study to investigate the optimal muscle relaxant during rapid sequence induction for facilitating tracheal intubation in the elderly.

Conditions

• Intubation Conditions

Interventions

Type	Name	Description
DRUG	Suxamethonium	1 mg/kg for tracheal intubation after 60 seconds
DRUG	Rocuronium	1 mg/kg for tracheal intubation after 60 seconds

Timeline

• Start date: 2021-08-12
• Primary completion: 2024-03-14
• Completion: 2024-03-17
• First posted: 2021-05-03
• Last updated: 2024-03-19

Locations

4 sites across 1 country: Denmark