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

Intubation Conditions Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04868409
• Other study ID #: H-20074958
• Status: Completed
• Phase: Phase 4
• Start date: August 12, 2021
• Est. completion date: March 17, 2024

Study information

• Verified date: March 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 17, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Age = 80
• Scheduled for surgery under general anesthesia with indication for rapid sequence induction
• American Society of Anesthesiologists physical status classification (ASA) I to IV
• Informed consent (see appendix 1)
• Body mass index (BMI) < 35 kg/m2
• Read and understand Danish

Exclusion Criteria:

• Neuromuscular disease
• Known allergy to rocuronium and/or suxamethonium
• Known hyperkalemia > 5 mM
• Previous malignant hyperthermia
• Known homozygote plasmacholinesterase gene mutation variant a or s
• Known impaired kidney function defined as estimated glomerular filtration rate (eGFR) < 30

Related Conditions & MeSH terms

• Disease
• Intubation Conditions

Intervention

Drug:
• Suxamethonium
1 mg/kg for tracheal intubation after 60 seconds
• Rocuronium
1 mg/kg for tracheal intubation after 60 seconds

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup	Glostrup
Denmark	Holbæk Hospital	Holbæk

Sponsors (1)

Lead Sponsor	Collaborator
Matias Vested

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation conditions	Tracheal intubating conditions according to the Fuchs-Buder scale: Excellent, good or poor depending on laryngoscopy, vocal chords and reaction to intubation,	60 seconds after induction of anaesthesia
Secondary	Time to tracheal intubation	• Time to tracheal intubation (from administration of muscle relaxant till correct placement of tracheal tube)	within 15 minutes after administration of muscle relaxant
Secondary	Time to TOF count 0	Time till no response from the nerve-stimulator after administration of muscle relaxant	within 15 minutes
Secondary	First pas succes rate	Succes of tracheal tube placement 60 seconds after administration of muscle relaxant	within 15 minutes
Secondary	Intubation conditions	Intubation conditions evaluated on the Intubation Difficulty Scale ranging from 0 (best) til 10 (worst)	within 15 minutes
Secondary	Desaturation	spO2 < 0.9	within 15 minutes
Secondary	cardiac arrythmia	Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes from administration of muscle relaxant)	within 15 minutes of anesthesia
Secondary	sore throat	blinded assessment of sore throat reported by the patient on a numerical ranking scale (0 best, 10 worst)	24 hours after anaesthesia
Secondary	muscle soreness	blinded assessment of muscle soreness reported by the patient on a numerical ranking scale (0 best, 10 worst)	24 hours after anaesthesia