Reduction of Rocuronium-induced Injection Pain With Aspiration of Blood

November 27, 2023 updated by: Chang Gung Memorial Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical trial uses a random table for sequential randomization, randomly assigning subjects to 3 groups, each consisting of 40 participants.

Researcher will confirm the patency of peripheral intravenous lines before induction. If peripheral intravenous lines cannot be used, they will be readministered at another injection site. If there are difficulties in peripheral intravenous injection, the participant will need to withdraw from this clinical trial. The neuromuscular monitoring device (NMT) is installed before the start of the clinical trial to monitor the effects of the drug. To avoid influencing the final results, fentanyl and 2%lidocaine will not be administered before injecting rocuronium. Anesthesia induction begins with the administration of oxygen through a mask to assist breathing. Initially, propofol is injected at a dose of 1.5 to 2mg/kg. Once the participant is confirmed to have lost consciousness, researchers will inject diluted rocuronium immediately, with an injection speed of 10 to 15 seconds. The dose of rocuronium for each participant is 0.8 mg/kg. The first group is pre-diluted with 2mL of normal saline, the second group with 2mL of 2%lidocaine, and the third group with 2mL of the participant's blood. To avoid clotting of blood, the procedure of the third group involves using a syringe containing rocuronium to withdraw 2mL of blood from the vein, followed by simultaneous injection into the intravenous line. The NMT is used to monitor the drug's effects, defining the onset time as the time from rocuronium injection to the disappearance of train-of-four (TOF) count T1 and the duration of action as the time from rocuronium injection to the appearance of TOF count T1.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: JIIN TARNG LIOU
  • Phone Number: +886975365735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: dilute with normal saline
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
rocuronium will be pre-diluted with 2mL of normal saline. Researchers will inject the mixture into intravenous catheter.
Other Names:
  • rocuronium
Active Comparator: dilute with 2%lidocaine
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
rocuronium will be pre-diluted with 2mL of 2%lidocaine. Researchers will inject the mixture into intravenous catheter.
Other Names:
  • rocuronium
Experimental: dilute with investigator's blood
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
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.
Other Names:
  • rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
withdrawal movement by 4-point-scale
Time Frame: From enrollment to the end of assessment at thirty minutes.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
onset time
Time Frame: From enrollment to the end of assessment at 3 minutes.
onset time is defined by injection of rocuronium mixture to the disappearance of Train-of-four count T1.
From enrollment to the end of assessment at 3 minutes.
duration of action
Time Frame: From enrollment to the end of assessment at one hour.
Duration of action is defined by injection of rocuronium mixture to appearance of Train-of-four count T1.
From enrollment to the end of assessment at one hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301309A3

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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