Comparison of the therapeutic effect of thiopental-fentanyl with propofol-fentanyl in providing sedation for reduction of anterior shoulder dislocation
Design
This study is a double-blind and two-phase clinical trial. Based on previous studies, 100 people were selected as the sample size.
Settings and conduct
This study was performed in the trauma emergency department of Ayatollah Mousavi Hospital as a double-blind trial. In this study, two types of pocket were used. Pocket A contained propofol and fentanyl and envelope B contained thiopental and fentanyl. According to the patient group, the pocket related to that patient was delivered to the nurse for drug injection. The drug was injected in the presence of the researcher by a nurse who injected the type of drug and knew its side effects, but the researcher was not aware of the type of drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study, People 18 to 40 years old with anterior shoulder dislocation
Exclusion criteria: People with fractures and major dislocations, Other major injuries with hemodynamic disturbances, History of substance abuse, People with allergies to any medications, Pregnancy
Intervention groups
In this study, two types of pocket were used. Pocket A contained propofol and fentanyl and envelope B contained thiopental and fentanyl. According to the patient group, the pocket related to that patient was delivered to the nurse for drug injection. The drug was injected in the presence of the researcher by a nurse who injected the type of drug and knew its side effects, but the researcher was not aware of the type of drug. It should be noted that patients did not know the type of sedative injectable.
Main outcome variables
Duration of sedation Two sedatives in three stages 1- Start of sedation 2- Between sedation and awakening 3- Between awakening to full consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210626051714N1
Registration date:2021-07-16, 1400/04/25
Registration timing:retrospective
Last update:2021-07-16, 1400/04/25
Update count:0
Registration date
2021-07-16, 1400/04/25
Registrant information
Name
Maryam Rouzi Talab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0000
Email address
maryamrouzitalab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
2019-12-22, 1398/10/01
Actual recruitment end date
2021-05-20, 1400/02/30
Trial completion date
2021-05-20, 1400/02/30
Scientific title
A comparison of sedation with thiopental–fentanyl versus propofol–fentanyl for anterior shoulder dislocation reduction in Emergency department
Public title
A comparison of sedation with thiopental–fentanyl versus propofol–fentanyl for anterior shoulder dislocation reduction in Emergency department
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
People 18 to 40 years old with anterior shoulder dislocation
Exclusion criteria:
Patients with fractures and major dislocations
Other major injuries with hemodynamic disturbances
History of substance abuse
Patients with allergies to any of the drugs
Pregnancy
Age
From 18 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected from 100 patients with anterior shoulder dislocation who referred to the trauma emergency department of Ayatollah Mousavi Hospital, Zanjan University of Medical Sciences. Samples were randomly divided into 50 subjects in the thiopental-fentanyl group and 50 subjects in the propofol-fentanyl group using a random number table. Sampling was continued until the number of samples in each group was completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was performed as a double-blind study. In this study, after obtaining informed consent, patients were randomly divided into two groups using a table of random numbers. In this study, two types of pocket were used. pocket A contained propofol and fentanyl and envelope B contained thiopental and fentanyl. According to the patient group, the pocket related to that patient was delivered to the nurse for drug injection. The drug was injected in the presence of the researcher by a nurse who injected the type of drug and knew its side effects, but the researcher was not aware of the type of drug. It should be noted that patients did not know the type of sedative injectable.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Deputy of Research and Technology of Zanjan University of Medical Sciences
Street address
Deputy of Research and Technology, third floor, Second building, Central Headquarters of Zanjan University of Medical Sciences, The beginning of Jomhuri Eslami Boulevard, Azadi Blv, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.ZUMS.REC.1398.220
Health conditions studied
1
Description of health condition studied
Anterior Shoulder Dislocations
ICD-10 code
S43.016A
ICD-10 code description
Anterior dislocation of unspecified humerus, initial encounter
Primary outcomes
1
Description
Duration of sedation in three stages 1- Start of sedation 2- Between sedation and awakening 3- Between awakening to full consciousness
Timepoint
1- Start of sedation 2- Between sedation and awakening 3- Between awakening to full consciousness
Method of measurement
Using a stopwatch
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group A patients, propofol - 0.5 mg / kg fentanyl µg/kg was used as intervention group A.
Category
Treatment - Drugs
2
Description
Intervention group: In group B, thiopental was used titrated to 1 mg / kg - fentanyl 1 µg/kg.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After completing the study, there is a plan to share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patents, clinical reports, analysis codes, and data coding systems (Dictionary).
When the data will become available and for how long
The start of the access period to the data of this study will be from Early 2022 and approximately 6 months after the publication of the results.
To whom data/document is available
The data from this study will be available to all people who can play a role in caring for Anterior Shoulder Dislocations patients, such as families, and healthcare workers.
Under which criteria data/document could be used
The researcher tend to use data to improve patients, especially Anterior Shoulder Dislocations patients.
From where data/document is obtainable
To receive information anyone can be use the following email:ngarjani@zums.ac.ir
What processes are involved for a request to access data/document
The data will be sended to the applicants after her introduction and the reason for the need for data.