NCT07169227

Brief Summary

Propofol and rocuronium may cause pain during intravenous injection. Various pharmacological agents are used to reduce the incidence and severity of injection pain. Among the most commonly used agents for this purpose are lidocaine, various opioids, ketamine, paracetamol, and dexmedetomidine. The aim of this study was to evaluate the comparative effect of intravenous dexmedetomidine and paracetamol versus lidocaine in preventing propofol- and rocuronium-induced pain during anesthesia induction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

September 5, 2025

Last Update Submit

September 5, 2025

Conditions

Propofol Injection PainRocuronium Injection Pain

Keywords

lidocainedexmedetomidineparacetamol

Outcome Measures

Primary Outcomes (1)

  • Rocuronium Withdrawal Movement Score

    Score evaluating involuntary withdrawal movements in response to rocuronium injection (0 = No movement, 1 = Movement only at the wrist, 2 = Movement involving the upper arm and shoulder of the injected arm, 3 = Widespread movement in multiple extremities or full-body withdrawal)

    Immediately after rocuronium injection

Secondary Outcomes (1)

  • Propofol Pain Score

    Immediately after propofol injection

Study Arms (3)

Lidocaine

ACTIVE COMPARATOR

Patients who were administered lidocaine before anesthesia induction.

Drug: Lidocaine %2 ampoule

Paracetamol

EXPERIMENTAL

Patients who were administered paracetamol before anesthesia induction.

Drug: paracetamol

Dexmedetomidine

EXPERIMENTAL

Patients who were administered dexmedetomidine before anesthesia induction.

Drug: Dexmedetomidine

Interventions

Lidocaine %2 ampouleDRUG

Patients who were administered 40 mg lidocaine.

Lidocaine
DexmedetomidineDRUG

Patients who were administered 0.25 mg/kg dexmedetomidine.

Dexmedetomidine
paracetamolDRUG

Patients who were administered 50 mg paracetamol.

Paracetamol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will receive propofol and rocuronium 18 - 65 years No psychiatric disorders Elective surgery Those who accept the research No history of allergy to any of the drugs used in the study Patients in American Society of Anesthesiologists (ASA) I and II class

You may not qualify if:

  • Patients with chronic pain syndromes Patients with difficult intravenous access Patients with advanced heart block or heart failure Patients with uncontrolled hypertension (Systolic blood pressure \>160 mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Adana, Adana, Turkey (Türkiye)

Location

Related Publications (3)

  • Uzun S, Erden IA, Canbay O, Aypar U. The effect of intravenous paracetamol for the prevention of rocuronium injection pain. Kaohsiung J Med Sci. 2014 Nov;30(11):566-9. doi: 10.1016/j.kjms.2014.08.002. Epub 2014 Sep 22.

    PMID: 25458046BACKGROUND

  • He L, Xu JM, He T, Liu L, Zhu R. Dexmedetomidine pretreatment alleviates propofol injection pain. Ups J Med Sci. 2014 Nov;119(4):338-42. doi: 10.3109/03009734.2014.941049. Epub 2014 Oct 24.

    PMID: 25342205BACKGROUND

  • Kwak HJ, Kim JY, Kim YB, Min SK, Moon BK, Kim JY. Pharmacological prevention of rocuronium-induced injection pain or withdrawal movements: a meta-analysis. J Anesth. 2013 Oct;27(5):742-9. doi: 10.1007/s00540-013-1595-7. Epub 2013 Mar 22.

    PMID: 23519582BACKGROUND

MeSH Terms

Interventions

DexmedetomidineAcetaminophen

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Sibel Çatalca, Dr.

    Baskent University, Adana Dr. Turgut Noyan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sibel Çatalca, Dr.

CONTACT

+90 322 327 27 27drsibelcatalca@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 11, 2025

Study Start

September 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)