Ephedrine for Reducing Onset Time of Rocurinium in Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-13

Study Completion Date

2025-12-31

Brief Summary

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The aim of this study is to determine the onset time of rocuronium after administration of ephedrine 0.15 mg/kg in patients with age ≥ 80 years. The hypothesis of this study is that ephedrine 0.15 mg/kg provides a shorter onset time compared to placebo (saline).

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Detailed Description

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Numbers of elderly patients requiring anesthesia and surgery are increasing, and as a group, elderly patients are at high risk of postoperative complications. Aging leads to a progressive impairment of organ function and a decline in physiologic reserve and in the elderly patient population, pharmacodynamics and pharmacokinetics of medications administered during anesthesia may be influenced by the age-related reduction in cardiac output, liver function and renal function. Also, the body composition changes with age and elderly have lower total body water and an increase in body fat.

Neuromuscular blocking agents (NMBAs) are administered during anesthesia to facilitate tracheal intubation. However, in elderly patients onset time of standard doses of NMBAs are prolonged, and for 0.6 mg/kg of rocuronium it is prolonged by 50% when comparing elderly with younger adults (median 135 seconds vs 90 seconds). A prolonged onset time of rocuronium may result in prolonged time to tracheal intubation which aims to secure the patients airway and breathing during anesthesia and thereby prevents pulmonary aspiration and hypoxia. It is therefore relevant to investigate measures to reduce onset time of rocuronium in the elderly.

Ephedrine administered in younger adults undergoing general anesthesia has reduced the onset time of rocuronium 0.6 mg/kg. The mechanism behind this is speculated to be an increase in cardiac output.

It is possible to detect onset time of NMBAs with objective neuromuscular monitoring perioperatively by train-of-four (TOF) stimulation at the ulnar nerve. The effect of ephedrine on onset time of rocuronium has not been assessed in elderly patients above 80 years of age.

The possible benefit of this trial is to investigate whether ephedrine 0.15 mg/kg reduces onset time of rocuronium 0.6 mg/kg in the elderly. This may result in a shorter time to tracheal intubation and also establish better intubating conditions. The results may help to detect the optimal method for administering rocuronium to facilitate tracheal intubation in elderly patients.

The investigators hypothesize that ephedrine 0.15 mg/kg will provide a shorter onset time of rocuronium compared to placebo (saline).

Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized study. Patients will be allocated randomly at a ratio of 1:1 to receive either 0.15 mg/kg ephedrine or saline (placebo). Randomization will be done at the day of operation after written informed consent is obtained. An independent investigator will allocate patients by using a computerized random number generator in REDCap. In REDCap patients also receive a number, which pseudo anonymizes data.

The study drug is prepared in the medicine room before the operation. This is done under double control by the investigator who also performed the randomization. The study drug, either ephedrine or saline, will be prepared in a 1 mL syringe. The dose will be mixed with saline to a total of 1 mL to secure blinding.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

* The surgeon will be blinded to treatment group allocation during the induction.
* The anesthesia personnel will be blinded to treatment group allocation during induction and intubation, but after gathering the data, they will be unblinded.
* The investigator controlling the nerve stimulator will be blinded throughout the whole procedure.
* Surgical personnel will be blinded to treatment group allocation during induction.

Study Groups

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Ephedrine group

Ephedrine 0.15 mg/kg. Dose of ephedrine is based on ideal body weight, calculated as height (cm) minus 105 for women and height (cm) minus 100 for men or actual body weight, whichever is lower.

Group Type ACTIVE_COMPARATOR

Ephedrine Hydrochloride 30 mg/ml

Intervention Type DRUG

0.15 mg/kg during induction.

Saline group

Saline 1 ml.

Group Type PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type DRUG

1 ml during induction.

Interventions

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Ephedrine Hydrochloride 30 mg/ml

0.15 mg/kg during induction.

Intervention Type DRUG

Saline (NaCl 0,9 %) (placebo)

1 ml during induction.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 80
* Scheduled for elective operations under general anesthesia with intubation
* American Society of Anesthesiologists physical status classification (ASA) I to III
* Informed consent
* Read and understand Danish

Exclusion Criteria

* Known allergy to rocuronium or ephedrine
* Neuromuscular disease that may interfere with neuromuscular data
* Indication for rapid sequence induction
* Daily use of beta-blocking agents
* Known cardiac arrythmia (atrial fibrillation, supraventricular or ventricular)

Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No