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

NCT ID: NCT05217238

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-18

Study Completion Date

2022-03-30

Brief Summary

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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

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Conditions

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Rocuronium Injection Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Advanced intravenous injection of remifentanil before the rocuronium injection

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.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Advanced intravenous injection of remifentanil before the rocuronium injection

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.

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Advanced intravenous injection of remifentanil before the rocuronium injection

Interventions

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Remifentanil

Advanced intravenous injection of remifentanil before the rocuronium injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yangzhou University

OTHER

Sponsor Role lead

Responsible Party

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Zhuan Zhang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhang Zhuan, professor

Role: primary

15062791355

References

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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.

Reference Type DERIVED
PMID: 36884108 (View on PubMed)

Other Identifiers

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20211218

Identifier Type: -

Identifier Source: org_study_id

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