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

Not Applicable

• Conditions: Rocuronium; Injection Pain
• Interventions: Drug: Remifentanil

• Registration Number: NCT05217238
• Lead Sponsor: Yangzhou University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-18
• Study First Submitted: 2021-12-18
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-31
• Last Update Submitted: 2022-01-31
• Study First Posted: 2022-02-01
• Last Update Posted: 2022-02-01
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Age range of 18 to 44 years olds	Remifentanil	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.
Age range of 45 to 59 years olds	Remifentanil	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.
Age range of 60 to 80 years olds	Remifentanil	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.

Primary Outcome Measures

Name	Time	Method
The appearance of intravenous injection pain Yes or No	an average of 2 minutes	Yes or No

Secondary Outcome Measures

Name	Time	Method
The levels of intravenous injection pain	an average of 2 minutes	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.

Trial Locations

Locations (1)

the Affiliated Hospital of Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China