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)

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.

Study Overview

• Status: Completed
• Conditions: Intubation Conditions
• Intervention / Treatment: Drug: Rocuronium; Drug: Suxamethonium

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Bispebjerg Hospital
  • Copenhagen, Denmark, 2830
    • Rigshospitalet
  • Glostrup, Denmark
    • Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup
  • Holbæk, Denmark
    • Holbæk Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rocuronium group; Rocuronium 1 mg/kg	Drug: Rocuronium; 1 mg/kg for tracheal intubation after 60 seconds; Other Names: Esmeron
Active Comparator: Suxamethonium group; Suxamethonium 1 mg/kg	Drug: Suxamethonium; 1 mg/kg for tracheal intubation after 60 seconds; Other Names: Succinylcholine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to TOF count 0	Time till no response from the nerve-stimulator after administration of muscle relaxant	within 15 minutes
First pas succes rate	Succes of tracheal tube placement 60 seconds after administration of muscle relaxant	within 15 minutes
Intubation conditions	Intubation conditions evaluated on the Intubation Difficulty Scale ranging from 0 (best) til 10 (worst)	within 15 minutes
Desaturation	spO2 < 0.9	within 15 minutes
cardiac arrythmia	Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes from administration of muscle relaxant)	within 15 minutes of anesthesia
sore throat	blinded assessment of sore throat reported by the patient on a numerical ranking scale (0 best, 10 worst)	24 hours after anaesthesia
muscle soreness	blinded assessment of muscle soreness reported by the patient on a numerical ranking scale (0 best, 10 worst)	24 hours after anaesthesia

Collaborators and Investigators

• Sponsor: Matias Vested
• Investigators: Study Chair: Lars S Rasmussen, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Actual): March 14, 2024
• Study Completion (Actual): March 17, 2024

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Rocuronium; Succinylcholine
• Other Study ID Numbers: H-20074958

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No