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

NCT04868409 | Completed Phase 4 DMC

• 1 other identifier: H-20074958
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Intubation Conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Time to tracheal intubation

  within 15 minutes after administration of muscle relaxant

• Time to TOF count 0

  within 15 minutes

• First pas succes rate

  within 15 minutes

• Intubation conditions

  within 15 minutes

• Desaturation

  within 15 minutes

Study Arms (2)

Rocuronium group

ACTIVE COMPARATOR

Rocuronium 1 mg/kg

Drug: Rocuronium

Suxamethonium group

ACTIVE COMPARATOR

Suxamethonium 1 mg/kg

Drug: Suxamethonium

Interventions

Suxamethonium DRUG

1 mg/kg for tracheal intubation after 60 seconds

Also known as: Succinylcholine

Suxamethonium group

Rocuronium DRUG

1 mg/kg for tracheal intubation after 60 seconds

Also known as: Esmeron

Rocuronium group

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matias Vested: lead

Study Sites (4)

Rigshospitalet

Copenhagen, 2830, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup

Glostrup Municipality, Denmark

Location

Holbæk Hospital

Holbæk, Denmark

Location

MeSH Terms

Interventions

Succinylcholine; Rocuronium

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lars S Rasmussen

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Model Details: Randomized study

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 3, 2021
• Study Start: August 12, 2021
• Primary Completion: March 14, 2024
• Study Completion: March 17, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)