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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05217238
Enrollment
70
Registered
2022-02-01
Start date
2021-12-18
Completion date
2022-03-30
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injection Pain, Rocuronium

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.

Interventions

DRUGRemifentanil

Advanced intravenous injection of remifentanil before the rocuronium injection

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
The appearance of intravenous injection pain Yes or Noan average of 2 minutesYes or No

Secondary

MeasureTime frameDescription
The levels of intravenous injection painan average of 2 minutesThe 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

MeasureTime frameDescription
If any adverse memory or pain during the induction of general anesthesiathe time one hour after turn into Postanesthesia care unitPatients 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026