Protocol summary

Summary
This study is a double-blind randomized clinical trial, on 150 patients, with the aim of the comparison of the success and complications in shoulders reduction with using three drug combination succinylcholine and thiopental "with" propofol and fentanyl "with" midazolam and fentanyl in Imam Hussein hospital of Tehran will be done. Inclusion criteria including patients 18 to 65 years old with anterior or posterior shoulder dislocation, Admitted to the emergency, consent to participate in the study and exclusion criteria included physical condition above III based on the ASA, patients with major fracture dislocation, other major injuries, history of drug abuse, patients with poisoning. Patients randomly with using random numbers table will be divided into three groups of 50 Patients. Before the reduction 20 mg succinylcholine and 3.5 mg/kg thiopental in the first group, 3-1 mg/kg propofol and 3-2 mg/kg of fentanyl in the second group and 5-3 mg of midazolam 3-2 mg/kg of fentanyl in the third group will be injected and patients after receiving sedation, emergency assistant will do all of the reduction with Liedelmayer maneuver. The success of the reduction will be monitored with X-ray and evaluated reduction in complications in three groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017032323559N10
Registration date: 2017-04-24, 1396/02/04
Registration timing: na

Last update:
Update count: 0
Registration date
2017-04-24, 1396/02/04
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the success and complications in shoulders reduction with using three drug combination succinylcholine and thiopental "with" propofol and fentanyl "with" midazolam and fentanyl in Imam Hussein hospital of Tehran.
Public title
Comparison of the three drug combination succinylcholine and thiopental "with" propofol and fentanyl "or" intravenous midazolam and fentanyl "success and complication reduction in shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients 18 to 65 years old with anterior or posterior shoulder dislocation; Admitted to the emergency; consent to participate in the study. Exclusion criteria: physical condition above III based on the ASA; patients with major fracture dislocation; other major injuries; history of drug abuse; patients with poisoning.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is double-blind. In this study, we have 2 types of envelopes. Envelopes A is containing dexamethasone and ondansetron and Envelopes B which contains dexamethasone and Plazil. Patients by executing and by table of random numbers divided into two A & B groups. According to Patient group, Envelopes For drugs injection will be delivered to anesthesia technician. Anesthesia technician does not know the type of injected drug.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Shahid Erabi St, Yaman St, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
1985717443
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SBMU.RAM.REC.1394.159

Health conditions studied

1

Description of health condition studied
Reduction of shoulders
ICD-10 code
S43.0
ICD-10 code description
Dislocation of shoulder joint

Primary outcomes

1

Description
Reduction success
Timepoint
Up to 5 minutes after reduction
Method of measurement
Checked by X-ray.

2

Description
Reduction complications
Timepoint
Until clearance
Method of measurement
Through examination of patient

Secondary outcomes

1

Description
Pain score
Timepoint
During reduction
Method of measurement
Based on VAS score

2

Description
Sedation score
Timepoint
During reduction
Method of measurement
Ramsey sedation score

Intervention groups

1

Description
The first group: consists of succinylcholine 20 mg and thiopental with 5.3 mg/kg dose(drugs prescription to titrated and slow injection)
Category
Treatment - Drugs

2

Description
The Second group: consists of propofol with 1-3 mg/kg doses and Fentanyl with 2-3 mg/kg dose(drugs prescription to titrated and slow injection)
Category
Treatment - Drugs

3

Description
The third group: includes a midazolam with 3-5 mg dose and fentanyl with 2-3 mg/kg dose(drugs prescription to titrated and slow injection)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hussein hospital
Full name of responsible person
Hamid kariman MD
Street address
Emam Hossein Hospital, Madani St, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin zarghi MD
Street address
College of Medicine, Kodakyari St, Shahid Shahriari Square, Shahid Chamran Highway, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamid kariman MD
Position
Associate Professor, Department of Emergency Medicine
Other areas of specialty/work
Street address
Emam Hossein Hospital, Madani St, Tehran
City
Tehran
Postal code
1415813714
Phone
+98 21 7755 8001
Fax
+98 21 7755 8001
Email
h.kariman49@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamid kariman MD
Position
Associate Professor, Department of Emergency Medicine
Other areas of specialty/work
Street address
Emam Hossein Hospital, Madani St, Tehran
City
Tehran
Postal code
1415813714
Phone
+98 21 7755 8001
Fax
+98 21 7755 8001
Email
h.kariman49@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamid kariman MD
Position
Associate Professor, Department of Emergency Medicine
Other areas of specialty/work
Street address
Emam Hossein Hospital, Madani St, Tehran
City
Tehran
Postal code
1415813714
Phone
+98 21 7755 8001
Fax
+98 21 7755 8001
Email
h.kariman49@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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