A randomized study comparing two types of muscle relaxants regarding the influence on tracheal intubation during anaesthesia in elderly patients (= 80 years old)

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

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005384-31-DK

Enrollment

Registered

2020-12-09

Start date

2021-03-19

Completion date

Unknown

Last updated

2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. MedDRA version: 23.1 Level: LLT Classification code 10051079 Term: Orthopedic procedure System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10000082 Term: Abdominal pain generalised System Organ Class: 100000004856

Interventions

Trade Name: Rocuronium Product Name: Rocuronium Pharmaceutical Form: Solution for injection INN or Proposed INN: ROCURONIUM Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

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) =65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: The aim of this study is to determine the proportion of excellent tracheal intubation conditions administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age = 80 years. ;Primary end point(s): The primary outcome is the proportion with excellent intubation conditions during the first attempt to intubate employing the Fuchs-Buder rating scale 60 seconds after administration of 1.0 mg/kg rocuronium or 1.0 mg/kg succinylcholine.;Timepoint(s) of evaluation of this end point: Examined during induction of anaesthesia	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: The aim of this study is to determine the proportion of excellent tracheal intubation conditions administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age = 80 years. ;Primary end point(s): The primary outcome is the proportion with excellent intubation conditions during the first attempt to intubate employing the Fuchs-Buder rating scale 60 seconds after administration of 1.0 mg/kg rocuronium or 1.0 mg/kg succinylcholine.;Timepoint(s) of evaluation of this end point: Examined during induction of anaesthesia

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Secondary

Measure	Time frame
Secondary end point(s): • Time to tracheal intubation (from administration of muscle relaxant till correct placement of tracheal tube) • First pass success rate • Time to TOF 0 • Intubation conditions (IDS) • Occurrence of desaturation = 90% (yes/no, from administration of NMBA until tracheal intubation). • Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes from administration of NMBA) • Occurrence of hoarseness and sore throat within 24 hours postoperatively • Occurrence of muscle soreness postoperatively (<24 hours) and if so at postoperative day 3 ;Timepoint(s) of evaluation of this end point: Within 24 hours postoperatively	—

Measure

Time frame

Secondary end point(s): • Time to tracheal intubation (from administration of muscle relaxant till correct placement of tracheal tube) • First pass success rate • Time to TOF 0 • Intubation conditions (IDS) • Occurrence of desaturation = 90% (yes/no, from administration of NMBA until tracheal intubation). • Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes from administration of NMBA) • Occurrence of hoarseness and sore throat within 24 hours postoperatively • Occurrence of muscle soreness postoperatively (<24 hours) and if so at postoperative day 3 ;Timepoint(s) of evaluation of this end point: Within 24 hours postoperatively

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Countries

Denmark

Contacts

Public ContactDepartment of Anesthesia

Rigshospitalet

lars.simon.rasmussen.01@regionh.dk35458043

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026