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

A Single-blinded Multicenter Randomized Interventional Study of Rocuronium 0.3 mg/kg, and 0.9 mg/kg Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Elderly Patients (≥ 80 Years).

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Intubation Complication; Neuromuscular Blockade; Neuromuscular Blockade, Residual
• Intervention / Treatment: Drug: Rocuronium 0,3mg/kg; Drug: Rocuronium 0,9mg/kg

Detailed Description

The number of elderly patients (>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia within the next decades. Elderly patients 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.

Rocuronium is a nondepolarizing neuromuscular blocking drug with an onset time of approximately 70 s and a clinical duration of action of approximately 50 min. according to previous studies. During anesthesia rocuronium is administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Rocuronium is primarily metabolized in the liver (70 % unmetabolized via the bile) and excreted via the kidneys.

Onset time and duration of action of rocuronium should be assessed by objective neuromuscular monitoring. Also, this reduces the risk of residual neuromuscular block which is defined as a train of four (TOF) ratio less than 0.9. Especially elderly patients have a high incidence of residual neuromuscular block.

The collected data regarding the effect of rocuronium in elderly patients may change the treatment so these patients receive the correct dose for optimal intubating conditions. Also, detection of duration of action of different doses of rocuronium may reduce the risk of residual block and postoperative respiratory complications

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group receiving rocuronium 0,3 mg/kg; Rocuronium 0,3 mg/kg at induction	Drug: Rocuronium 0,3mg/kg; Rocuronium 0,3mg/kg at induction; Other Names: Rocuronium
ACTIVE_COMPARATOR: Group receiving rocuronium 0,9 mg/kg; Rocuronium 0,9 mg/kg at induction	Drug: Rocuronium 0,9mg/kg; Rocuronium 0,9mg/kg at induction; Other Names: Rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of action of rocuronium	Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.	intraoperative (Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.)
Evaluation of intubating conditions ad modum Fuchs-Buder et al	Intubating conditions are rated by an intubating difficulty scale according to Fuchs-Buder et al.	intraoperative (From train-of-four (TOF) count of 0 till)

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2020
• Primary Completion (ACTUAL): May 18, 2021
• Study Completion (ACTUAL): May 25, 2021

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: H-19079175

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