Completed

The Effect of Esmolol on Pain Due to Rocuronium Injection Pain

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What is being tested

Esmolol

+ rocuronium

+ Lidocaine

Drug
Who is being recruted

From 18 to 70 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-ControlledPhase 4
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorAnkara Diskapi Training and Research Hospital
Last updated: October 4, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

Patients will be observed after injection of rocuronium 0.05mg/kg, then immediately asked if they have pain in the arm. The response are assessed; discomfort, pain, and withdrawal of the hand are recorded and graded using a 4-point scale (none, mild, moderate, or severe). After the intubating dose of rocuronium, withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.

NCT01824758
Principal SponsorAnkara Diskapi Training and Research Hospital
Last updated: October 4, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
ASA physical status I and II patients
Undergoing general anesthesia for elective surgery
4 exclusion criteria prevent from participating
Chronic pain
Known allergy to esmolol or lidocaine
Pregnancy
Withdrawal of consent by the patient

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Group E will receive esmolol (1 mg/kg), Group L lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL)

Group II

Active Comparator
Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)

Group III

Placebo
Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Diskapi Teaching and Research Hospital

Ankara, Turkey (Türkiye)Open Diskapi Teaching and Research Hospital in Google Maps
CompletedOne Study Center