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Completed

NCT Number: NCT05457751

The Effect of Orally Administered Metoprolol on the Frequency and Severity of Rocuronium Injection Pain

In this study, we aimed to investigate the effect of metoprolol on the frequency and severity of pain caused by rocuronium injection in patients who started to use and were currently using oral metoprolol for any reason such as ischemic heart disease, hypertension, and arrhythmias. All patients were informed about the objectives of the study and gave informed written consent. The study was conducted in accordance with the relevant ethical principles of the Declaration of Helsinki. This study was planned as a prospective, placebo-controlled, cohort study were evaluated in four groups. Group M: patients currently using metoprolol and who did not receive lidocaine before the application of rocuronium. Group ML: patients currently using metoprolol and who received lidocaine before rocuronium application. Group L: patients currently not using metoprolol and received lidocaine before rocuronium application. Group C: patients currently not using metoprolol and who did not receive lidocaine before rocuronium application. 200 patients with 50 being in each of four groups were included in the study.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

Following the induction of general anesthesia with thiopental sodium, a researcher blind to the groups observed the pain during rocuronium injection based on the following scale:

1: no reaction, 2: movement only in the ankle, 3: movement or withdrawal only in the arm (shoulder and ankle), 4: diffuse reaction (movement or withdrawal in more than one extremity, coughing and holding breath).Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and SpO2 values were recorded before rocuronium administration, 1 and 3 minutes after rocuronium induction, and after intubation. Anesthesia maintenance was performed according to the discretion of the anesthetist. We checked the injection site regarding edema, rash, and thrombophlebitis after the first 24 hours of the operation.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-75 years, ASA I-III, patients who received general anesthesia, patients who were using oral metoprolol for any reason such as ıschemic heart disease, arrhythmias.

Exclusion criteria

  • Patients under 18 and above 75 years of age, with ASA IV class, those with known allergy to rocuronium and lidocaine, patients with chronic pain, pregnant women, those who had received analgesics or sedatives, and patients who were receiving calcium channel blocker that could affect pain were excluded from the study.

Treatment and study plan

Rocuronium injection pain

Procedure

1: no reaction, 2: movement only in the ankle, 3: movement or withdrawal only in the arm (shoulder and ankle), 4: diffuse reaction (movement or withdrawal in more than one extremity, coughing and holding breath

Primary outcomes

  1. Rocuronium injection pain

    Time frame: İntraoperative

    1: no reaction, 2: movement only in the ankle, 3: movement or withdrawal only in the arm (shoulder and ankle), 4: diffuse reaction (movement or withdrawal in more than one extremity, coughing and holding breath

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2022
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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