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

NCT ID: NCT04868409

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-12
• Study Completion Date: 2024-03-17

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Rocuronium group

Rocuronium 1 mg/kg

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

1 mg/kg for tracheal intubation after 60 seconds

Suxamethonium group

Suxamethonium 1 mg/kg

Group Type: ACTIVE_COMPARATOR

Suxamethonium

Intervention Type: DRUG

1 mg/kg for tracheal intubation after 60 seconds

Interventions

Suxamethonium

1 mg/kg for tracheal intubation after 60 seconds

Intervention Type: DRUG

Rocuronium

1 mg/kg for tracheal intubation after 60 seconds

Intervention Type: DRUG

Other Intervention Names

Succinylcholine; Esmeron

Eligibility 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) < 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

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Matias Vested

OTHER

Sponsor Role: lead

Responsible Party

Matias Vested

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lars S Rasmussen

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Bispebjerg Hospital

Copenhagen, , Denmark

Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup

Glostrup Municipality, , Denmark

Holbæk Hospital

Holbæk, , Denmark

Countries

Denmark

Other Identifiers

H-20074958

Identifier Type: -

Identifier Source: org_study_id