Median Effective Dose of Remifentanil for the Prevention of Pain Caused by the Injection of Rocuronium

NCT05217238 | Unknown

• 1 other identifier: 20211218
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

As a medium-and long-term non-depolarizing muscle relaxant, rocuronium has the advantages of quick effect, no histamine release and accumulation and no obvious cardiovascular adverse reactions, so it has been widely used in clinical anesthesia induction. However, when given intravenously, rocuronium can cause adverse reactions such as injection pain and limb retraction, which can lead to needle prolapse, extravasation of injection drugs, swelling of injection site, serious induction delay, and cardiovascular adverse events in severe cases. Remifentanil is a synthetic opioid drug hydrolyzed by esterase. Compared with other opioid drugs, remifentanil has the advantages of quick effect, short half-life and short time of hemodynamic changes, so it is an ideal analgesic in clinical anesthesia. In this study, in order to provide clinical references, sequential method was used to find the median effective dose (ED50) by means of pre-intravenous injection of Remifentanil to suppress pain in rocuronium injection.

Conditions

Rocuronium; Injection Pain

Outcome Measures

Primary Outcomes (1)

• The appearance of intravenous injection pain Yes or No

  Yes or No

  an average of 2 minutes

Secondary Outcomes (1)

• The levels of intravenous injection pain

  an average of 2 minutes

Other Outcomes (1)

• If any adverse memory or pain during the induction of general anesthesia

  the time one hour after turn into Postanesthesia care unit

Study Arms (3)

Age range of 18 to 44 years olds

EXPERIMENTAL

The initial dose of lidocaine for pre-injection was set at 1ug/kg according to previous literature and preliminary test results. The dose of remifentanil was according to the patients' pain level. If there is no pain (negative reaction), the dose of remifentanil in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of remifentanil will be increased in the next patient until the patient is painless.

Drug: Remifentanil

Age range of 45 to 59 years olds

EXPERIMENTAL

The initial dose of lidocaine for pre-injection was set at 1ug/kg according to previous literature and preliminary test results. The dose of remifentanil was according to the patients' pain level. If there is no pain (negative reaction), the dose of remifentanil in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of remifentanil will be increased in the next patient until the patient is painless.

Drug: Remifentanil

Age range of 60 to 80 years olds

EXPERIMENTAL

The initial dose of lidocaine for pre-injection was set at 1ug/kg according to previous literature and preliminary test results. The dose of remifentanil was according to the patients' pain level. If there is no pain (negative reaction), the dose of remifentanil in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of remifentanil will be increased in the next patient until the patient is painless.

Drug: Remifentanil

Interventions

Remifentanil DRUG

Advanced intravenous injection of remifentanil before the rocuronium injection

Age range of 18 to 44 years olds; Age range of 45 to 59 years olds; Age range of 60 to 80 years olds

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages ranged from 18 to 80.
• ASA # or # level.

You may not qualify if:

• Allergy or contraindication to remifentanil or rocuronium; required for Central venipuncture catheterization;
• Abnormal liver or kidney function;
• Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;
• Hearing and language impairment;
• Peripheral vascular disease;
• Severe cardiovascular disease or neurological disorders;
• Failure of one-time peripheral venipuncture;
• Infection of hand or wrist skin.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225000, China

RECRUITING

Related Publications (1)

• Yan S, Wu H, Yu Y, Li N, Yu L, Wang Y, Li H, Zhang D, Zhang Z. Median Effective Dose of Remifentanil for the Prevention of Pain Caused by the Injection of Rocuronium: An Age-Stratified Study. Pain Ther. 2023 Jun;12(3):683-694. doi: 10.1007/s40122-023-00490-5. Epub 2023 Mar 8.

  PMID: 36884108 DERIVED

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: February 1, 2022
• Study Start: December 18, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

CN (1)