A Comparison of Rocuronium 0.3 mg/kg, and 0.9 mg/kg for Induction of Anesthesia in Elderly Patients.

NCT04512313 | Completed DMC

• 1 other identifier: H-19079175
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The number of elderly patients above 80 years is increasing and a large proportion of these patients will require surgery and anesthesia. During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. There is a risk of residual neuromuscular block when using NMBAs like rocuronium. The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.

Conditions

Neuromuscular Blockade; Neuromuscular Blockade, Residual; Anesthesia; Intubation Complication

Outcome Measures

Primary Outcomes (1)

• Rocuronium onset time

  Time from start of rocuronium injection to train-of-four (TOF) count of 0

  intraoperative (From start of rocuronium injection to train-of-four (TOF) count of 0)

Secondary Outcomes (2)

• Duration of action of rocuronium

  intraoperative (Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.)

• Evaluation of intubating conditions ad modum Fuchs-Buder et al

  intraoperative (From train-of-four (TOF) count of 0 till)

Study Arms (2)

Group receiving rocuronium 0,3 mg/kg

ACTIVE COMPARATOR

Rocuronium 0,3 mg/kg at induction

Drug: Rocuronium 0,3mg/kg

Group receiving rocuronium 0,9 mg/kg

ACTIVE COMPARATOR

Rocuronium 0,9 mg/kg at induction

Drug: Rocuronium 0,9mg/kg

Interventions

Rocuronium 0,3mg/kg DRUG

Rocuronium 0,3mg/kg at induction

Also known as: Rocuronium

Group receiving rocuronium 0,3 mg/kg

Rocuronium 0,9mg/kg DRUG

Rocuronium 0,9mg/kg at induction

Also known as: Rocuronium

Group receiving rocuronium 0,9 mg/kg

Eligibility Criteria

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

You may qualify if:

• Age ≥ 80
• Scheduled to elective surgery (expected duration time of surgery \> 1 hour) under general anesthesia with intubation and use of rocuronium.
• American Society of Anesthesiologists (ASA) physical status classification I to III
• Informed consent (see appendix 1)
• Read and understand Danish

You may not qualify if:

• Neuromuscular disease
• Known allergy to rocuronium
• Prone position
• Indication for rapid sequence induction

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

• Wadland SS, Rasmussen LS, Vested M. Shortened time to neuromuscular recovery with lower doses of rocuronium in elderly patients. Dan Med J. 2024 May 13;71(6):A09230578. doi: 10.61409/A09230578.

  PMID: 38847412 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Matias Vested, MD, PhD

  Department of Anaesthesia, Head and Orthopaedics Centre, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist, MD, PhD

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 13, 2020
• Study Start: December 17, 2020
• Primary Completion: May 18, 2021
• Study Completion: May 25, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)