Reduction of Rocuronium-induced Injection Pain With Aspiration of Blood

NCT06150001 | Completed

• 1 other identifier: 202301309A3
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about reduction of rocuronium injection pain in participants receiving general anesthesia. The main question aims to answer is whether diluting rocuronium with blood can reduce rocuronium injection pain. Rocuronium is a rapid onset muscle relaxant used in general anesthesia. Lidocaine is a local anesthetic. Researchers will • inject diluted rocuronium in participant's intravenous catheter during induction. • record withdrawal movement and rocuronium onset time and duration measured by train-of-four (TOF). Researchers will compare between rocuronium diluted with blood, lidocaine and normal saline to see if blood can reduce rocuronium injection pain.

Conditions

Anesthesia, General

Keywords

rocuronium; injection pain; withdrawal movement; rocuronium injection pain; rocuronium withdrawal movement

Outcome Measures

Primary Outcomes (1)

• withdrawal movement by 4-point-scale

  withdrawal movement is measured by 4-point-scale. Zero is equivalent to no withdrawal movement. One is equivalent to withdrawal movement involving wrist joint. Two is equivalent to withdrawal movement involving elbow joint. Three is equivalent to withdrawal movement involving shoulder joint

  From enrollment to the end of assessment at thirty minutes.

Secondary Outcomes (2)

• onset time

  From enrollment to the end of assessment at 3 minutes.

• duration of action

  From enrollment to the end of assessment at one hour.

Study Arms (3)

dilute with normal saline

PLACEBO COMPARATOR

Researchers will dilute rocuronium at a dose of 0.8mg/kg with 2mL of normal saline. The rocuronium mixture will be injected into participants intravenous catheter.

Drug: rocuronium-normal-saline mixture

dilute with 2%lidocaine

ACTIVE COMPARATOR

Researchers will dilute rocuronium at a dose of 0.8mg/kg with 2mL of 2%lidocaine. The rocuronium mixture will be injected into participants intravenous catheter.

Drug: rocuronium-lidocaine mixture

dilute with investigator's blood

EXPERIMENTAL

Researchers will dilute rocuronium at a dose of 0.8mg/kg with 2mL of blood. The rocuronium mixture will be injected into participants intravenous catheter.

Drug: rocuronium-blood mixture

Interventions

rocuronium-normal-saline mixture DRUG

rocuronium will be pre-diluted with 2mL of normal saline. Researchers will inject the mixture into intravenous catheter.

Also known as: rocuronium

dilute with normal saline

rocuronium-lidocaine mixture DRUG

rocuronium will be pre-diluted with 2mL of 2%lidocaine. Researchers will inject the mixture into intravenous catheter.

Also known as: rocuronium

dilute with 2%lidocaine

rocuronium-blood mixture DRUG

Researchers will connect a syringe which contains 0.8mg/kg of rocuronium intravenous catheter, and then withdraw blood into the syringe. Finally inject the mixture into intravenous catheter.

Also known as: rocuronium

dilute with investigator's blood

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the written informed consent form.
• Males and females aged 18 to 65.
• Undergoing endotracheal intubation under general anesthesia.
• Anesthesia physical status classification II or below.

You may not qualify if:

• estimated glomerular filtration rate less than 60
• History of cirrhosis or liver failure
• Neuromuscular disease or neurological symptoms
• Mental illness
• Arrhythmia

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

ChangGung MH

Taoyuan District, 33380, Taiwan

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 29, 2023
• Study Start: December 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 22, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)