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

NCT ID: NCT04582032

Last Updated: 2021-01-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-01-04

Brief Summary

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

Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?

Detailed Description

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Purpose : Rocuronium bromide is a painful agent while general anesthesia induction. 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. Mild movement response to injection
2. Hand withdrawal response to injection
3. Arm withdrawal response to injection Investigators also evaluated the pain with 2 questions when the patient was in the recovery room.

Question 1.What was the last feeling before participants fall into sleep? question 2. Did participants feel any pain on participants's hand during medication injection for anesthesia?

Conditions

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Injection Site Irritation

Keywords

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dexketoprofen, pain, rocuronium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Dexketoprofen group,

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

Group Type ACTIVE_COMPARATOR

Dexketoprofen (KETAVEL 50 mg/2 ml)

Intervention Type DRUG

intravenous dexketoprofen (KETAVEL 50 mg/2 ml)

Saline group

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

Group Type OTHER

Saline (Isotonic Saline Solution 0.9% )

Intervention Type DRUG

intravenous 2 ml of saline

Interventions

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Dexketoprofen (KETAVEL 50 mg/2 ml)

intravenous dexketoprofen (KETAVEL 50 mg/2 ml)

Intervention Type DRUG

Saline (Isotonic Saline Solution 0.9% )

intravenous 2 ml of saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* non allergic to dexketoprofen
* 18-60 years old
* American Society of Anesthesiologists(ASA) 1-2-3
* 70-90 kg weigh

Exclusion Criteria

* patients with psychiatric and mental problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Mehmet sahap

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kecioren Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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roc

Identifier Type: -

Identifier Source: org_study_id