Effects of Cyclooxygenase (COX) 1-2 Inhibitors on Prevention of Rocuronium Injection Pain

NCT04582032 | Completed

• 1 other identifier: roc
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose : The aim of the study is to investigate the effects of cox inhibitors as a rescue agent against the rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a scale showed below. 0;No movement response to injection

1. 1.Mild movement response to injection
2. 2.Hand withdrawal response to injection
3. 3.Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room.

Conditions

Injection Site Irritation

Keywords

dexketoprofen, pain, rocuronium

Outcome Measures

Primary Outcomes (1)

• The injection pain due to rocuronium

  Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).

  1 month

Secondary Outcomes (1)

• Score on pain due to injection of rocuronium

  1 month

Study Arms (2)

Dexketoprofen group,

ACTIVE COMPARATOR

IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in dexketoprofen group were administered intravenous dexketoprofen (50 mg/2ml) and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction

Drug: Dexketoprofen (KETAVEL 50 mg/2 ml)

Saline group

OTHER

IV cannulation was performed on hand dorsum or brachial and canulation place was recorded. Patients allocated in control group were administered intravenous 2 ml of saline and 0,3 mg/kg midazolam 10 minutes prior to general anesthesia induction

Drug: Saline (Isotonic Saline Solution 0.9% )

Interventions

Dexketoprofen (KETAVEL 50 mg/2 ml) DRUG

intravenous dexketoprofen (KETAVEL 50 mg/2 ml)

Dexketoprofen group,

Saline (Isotonic Saline Solution 0.9% ) DRUG

intravenous 2 ml of saline

Saline group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non allergic to dexketoprofen
• years old
• American Society of Anesthesiologists(ASA) 1-2-3
• kg weigh

You may not qualify if:

• patients with psychiatric and mental problems

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Kecioren Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

dexketoprofen trometamol; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 9, 2020
• Study Start: November 1, 2020
• Primary Completion: December 4, 2020
• Study Completion: January 4, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)