Ephedrine for Reducing Onset Time of Rocurinium in Elderly Patients

NCT06681662 | Recruiting Phase 4 DMC

• 1 other identifier: Ephedrine for rocuronium
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Onset time of rocuronium 0.6 mg/kg defined as the time from administration of rocuronium until TOF count of 0.

  Onset time is determined by an investigator using a stop-watch.

  Within 1 hour

Secondary Outcomes (5)

• Intubating conditions assessed by The Intubation Difficulty Scale (IDS)

  Within 1 hour

• Intubating conditions assessed by Fuchs-Buder scale

  Within 1 hour

• Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes after administration of ephedrine or saline)

  Within 15 minutes

• Change in mean arterial blood pressure from before induction to immediately after intubation

  Within 1 hour

• Time to TOF 0.9

  Within 4 hours

Other Outcomes (1)

• Occurrence of hoarseness and sore throat 24 and 72 hours postoperatively

  Within 72 hours

Study Arms (2)

Ephedrine group

ACTIVE COMPARATOR

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.

Drug: Ephedrine Hydrochloride 30 mg/ml

Saline group

PLACEBO COMPARATOR

Saline 1 ml.

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

Ephedrine Hydrochloride 30 mg/ml DRUG

0.15 mg/kg during induction.

Ephedrine group

Saline (NaCl 0,9 %) (placebo) DRUG

1 ml during induction.

Saline group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Matias Vested: lead

Study Sites (2)

Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup

Copenhagen, 2100, Denmark

RECRUITING

Department of Anesthesia, Centre of Head and Orthopedics, 6013 Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Ephedrine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Matias Vested

  Rigshospitalet, University of Copenhagen

  STUDY CHAIR

Central Study Contacts

Matias Vested, MD, PhD

CONTACT

+45 35 45 75 47; matias.vested@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: * 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor, PhD

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: January 13, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)