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

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.

Study Overview

• Status: Recruiting
• Conditions: Rocuronium; Injection Pain
• Intervention / Treatment: Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225000
      • Recruiting
      • The Affiliated Hospital of Yangzhou University
      • Contact: Zhang Zhuan, professor; Phone Number: 15062791355; Email: zhangzhuanjy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Age range of 18 to 44 years olds; 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; Advanced intravenous injection of remifentanil before the rocuronium injection
Experimental: Age range of 45 to 59 years olds; 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; Advanced intravenous injection of remifentanil before the rocuronium injection
Experimental: Age range of 60 to 80 years olds; 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; Advanced intravenous injection of remifentanil before the rocuronium injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The appearance of intravenous injection pain Yes or No	Yes or No	an average of 2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yangzhou University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2021
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: December 18, 2021
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 20211218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No