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

Rocuronium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05217238
• Other study ID #: 20211218
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: January 2022
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Ages ranged from 18 to 80.

2. ASA # or # level.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Injection Pain
• Rocuronium

Intervention

Drug:
• Remifentanil
Advanced intravenous injection of remifentanil before the rocuronium injection

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	If any adverse memory or pain during the induction of general anesthesia	Patients recalled by visual analogue scale (VAS) to assess injection pain level : Mark 0 is painless. Mark 10 is violent pain, The numbers between them was pain of varying degrees.	the time one hour after turn into Postanesthesia care unit
Primary	The appearance of intravenous injection pain Yes or No	Yes or No	an average of 2 minutes
Secondary	The levels of intravenous injection pain	The intravenous injection pain in this study was divided into the following 5 levels according to its severity: level 0: After repeated questioning, the patient did not feel any abnormal sensation; level 1: upon inquiry, the patient felt swelling at the intravenous injection site; Level 2: Upon inquiry, the patient felt pain and had no body movement reaction (facial pain expression, arm withdrawal, tears, etc.); Level 3: Upon inquiry, the patient had pain and body movement reaction.; Or complain of pain without inquiry; Level 4: the patient has a strong reaction and body movement reaction. Level 2 and above is defined as injection pain.	an average of 2 minutes