The Effect of Orally Administered Metoprolol on the Frequency and Severity of Rocuronium Injection Pain
July 11, 2022 updated by: Ozlem Sen, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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.
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
200
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
A total of 200 patients, with 50 being in each group, were included in the study.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
M
Group M: patients currently using metoprolol and who did not receive lidocaine before the application of rocuronium.
|
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
|
|
ML
Group ML: patients currently using metoprolol and who received lidocaine before rocuronium application.
|
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
|
|
L
Group L: patients currently not using metoprolol and received lidocaine before rocuronium application.
|
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
|
|
C
Group C: patients currently not using metoprolol and who did not receive lidocaine before rocuronium application.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
İntraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2014
Primary Completion (Actual)
November 15, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
July 11, 2022
First Submitted That Met QC Criteria
July 11, 2022
First Posted (Actual)
July 14, 2022
Study Record Updates
Last Update Posted (Actual)
July 14, 2022
Last Update Submitted That Met QC Criteria
July 11, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20144
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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