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

Sponsor
Yangzhou University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05217238
Collaborator
(none)
70
1
3
3.4
20.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Median Effective Dose of Remifentanil for the Prevention of Pain Caused by the Injection of Rocuronium
Actual Study Start Date :
Dec 18, 2021
Anticipated Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Mar 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The appearance of intravenous injection pain Yes or No [an average of 2 minutes]

    Yes or No

Secondary Outcome Measures

  1. 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.

Other Outcome Measures

  1. If any adverse memory or pain during the induction of general anesthesia [the time one hour after turn into Postanesthesia care unit]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 the Affiliated Hospital of Yangzhou University Yangzhou Jiangsu China 225000

Sponsors and Collaborators

  • Yangzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhuan Zhang, Director, Yangzhou University
ClinicalTrials.gov Identifier:
NCT05217238
Other Study ID Numbers:
  • 20211218
First Posted:
Feb 1, 2022
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2022