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

Primary Purpose

Neuromuscular Blockade, Neuromuscular Blockade, Residual, Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Rocuronium 0,3mg/kg
Rocuronium 0,9mg/kg
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Blockade

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group receiving rocuronium 0,3 mg/kg

Group receiving rocuronium 0,9 mg/kg

Arm Description

Rocuronium 0,3 mg/kg at induction

Rocuronium 0,9 mg/kg at induction

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of action of rocuronium
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.

Full Information

First Posted
August 11, 2020
Last Updated
June 2, 2021
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04512313
Brief Title
A Comparison of Rocuronium 0.3 mg/kg, and 0.9 mg/kg for Induction of Anesthesia in Elderly Patients.
Official Title
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).
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Blockade, Neuromuscular Blockade, Residual, Anesthesia, Intubation Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group receiving rocuronium 0,3 mg/kg
Arm Type
Active Comparator
Arm Description
Rocuronium 0,3 mg/kg at induction
Arm Title
Group receiving rocuronium 0,9 mg/kg
Arm Type
Active Comparator
Arm Description
Rocuronium 0,9 mg/kg at induction
Intervention Type
Drug
Intervention Name(s)
Rocuronium 0,3mg/kg
Other Intervention Name(s)
Rocuronium
Intervention Description
Rocuronium 0,3mg/kg at induction
Intervention Type
Drug
Intervention Name(s)
Rocuronium 0,9mg/kg
Other Intervention Name(s)
Rocuronium
Intervention Description
Rocuronium 0,9mg/kg at induction
Primary Outcome Measure Information:
Title
Rocuronium onset time
Description
Time from start of rocuronium injection to train-of-four (TOF) count of 0
Time Frame
intraoperative (From start of rocuronium injection to train-of-four (TOF) count of 0)
Secondary Outcome Measure Information:
Title
Duration of action of rocuronium
Description
Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.
Time Frame
intraoperative (Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.)
Title
Evaluation of intubating conditions ad modum Fuchs-Buder et al
Description
Intubating conditions are rated by an intubating difficulty scale according to Fuchs-Buder et al.
Time Frame
intraoperative (From train-of-four (TOF) count of 0 till)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matias Vested, MD, PhD
Organizational Affiliation
Department of Anaesthesia, Head and Orthopaedics Centre, Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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