A Comparison of Rocuronium 0.6 mg/kg and Remifentanil 2 µg/kg in Elderly Patients Over 80 Years

A Single-blinded Multicenter Randomized Study Comparing Intubating Conditions After Either Rocuronium 0.6 mg/kg or Remifentanil 2 µg/kg in Elderly Patients

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.

Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen.

It is unknown which is superior concerning intubating conditions in elderly patients. Therefore, the aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Intubation Complication; Neuromuscular Blockade
• Intervention / Treatment: Drug: Rocuronium 0.6 mg/kg; Drug: Remifentanil 2 µg/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.

During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Studies suggests that avoidance of neuromuscular blocking agents (NMBAs) increases the risk of difficult tracheal intubation and leads to impaired intubating conditions with direct laryngoscopy. Furthermore, avoidance of NMBA significantly increases the risk of upper airway discomfort or injury. Even low doses of rocuronium may be associated with a significant improvement of intubating conditions.

Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen.

The possible benefit in this trial is to investigate whether rocuronium 0.6 mg/kg or remifentanil 2 µg/kg provides best intubating conditions in the elderly. This may result in different intubating difficulty scores between the two groups of elderly patients. The results may help to detect the optimal method for intubation of the trachea in elderly patients.

The aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Glostrup, Denmark, 2600
    • Rigshospitalet, Glostrup

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 for elective operations (expected duration of anesthesia > 1 hour) under general anesthesia with intubation
• American Society of Anesthesiologists physical status classification (ASA) I to III
• Informed consent (see appendix 1)
• Read and understand Danish

Exclusion Criteria:

• Neuromuscular disease
• Known allergy to rocuronium, remifentanil or sugammadex
• Rapid sequence induction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group receiving rocuronium at induction; Rocuronium 0,6 mg/kg at induction	Drug: Rocuronium 0.6 mg/kg; Rocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil
Active Comparator: Group receiving remifentanil at induction; Remifentanil 2 μg/kg at induction	Drug: Remifentanil 2 µg/kg; Rocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of intubating conditions ad modum Fuchs-Buder et al	Occurrence of excellent intubating conditions 2 minutes after start of administration of 0.6 mg/kg rocuronium or 2 µg/kg remifentanil, scored according to Fuchs-Buder et al. The intubating conditions will be classified as excellent if all qualities are excellent, good if all qualities are either excellent or good and poor if the presence of a single quality is listed as poor.	2 minutes after start of administration of trial medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective side effects of laryngoscopy	After 24 hours patients are asked about hoarseness and sore throat. The patients who experience either or both will be called 3 days postoperatively again. These two variables are assessed using a numeric ranking scale.	24 hours postoperatively and 3 days postoperatively
Dose of ephedrine or dose of metaoxedrine administered	If ephedrine and/or metaoxedrine is administered in the time period from induction until the patient is ready to be positioned for surgery it will be noted in the CRF. The amount administered will also be noted in the CRF. Changes in blood pressure are treated according to local guidelines.	From induction until the patient is ready to be positioned for surgery, ranging from 5 minutes up to 1 hour.
Intubating conditions according to IDS	Another way of rating intubating conditions are by an intubating difficulty scale (Table 2) (20) 2 minutes after injection of rocuronium/remifentanil. The investigator performing the intubation will be handed the CRF where he/she will fill out Table 2. Furthermore, investigator will note if a stylet or video laryngoscope has been used.	2 minutes after start of administration of trial medication

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Anne Marie Sørensen, MD, PhD, Department of Neuroanaesthesia, Rigshospitalet, Glostrup, Denmark

Publications and helpful links

General Publications

• Vested M, Sorensen AM, Bjerring C, Christensen RE, Dinesen F, Vang M, Gilvanoff A, Hansen TE, Nielsen T, Rasmussen LS. A blinded randomized study comparing intubating conditions after either rocuronium 0.6 mg.kg-1 or remifentanil 2 microg.kg-1 in elderly patients. Acta Anaesthesiol Scand. 2021 Nov;65(10):1367-1373. doi: 10.1111/aas.13957. Epub 2021 Sep 5.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): December 13, 2020

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Remifentanil; Rocuronium
• Other Study ID Numbers: H-19070343; 2019-004121-25 (EudraCT Number)

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