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The Comparison of different dosage of Ketofol for Procedural Sedation and Analgesia in the Emergency Department :a Randomized,Prospective,Double-Blind Trial

Protocol summary

Summary
Nowadays,sedative or dissociative agents are administered with or without analgesics to reduce pain and increase ease of procedure performance. (1)Objectives: In this study,we aim to compare the different dosage of ketofol for efficacy and adverse events in emergency procedural sedation. (2)Design: According to a random-number table,patients are randomized to four groups of different dosage of ketofol. Group A:infusion mixture in 1:1 ratio, 2:1 ratio (group B), 3 : 1 ratio (Group C), 4 :1 ratio(Group D). (3)Setting and conduct :In this double-blind study ,opaque syringes are administered for blinding.patients will be sedated to reach Ramsay sedation score of 3 or 4. (4)Participants including major eligibility criteria:Patients 14 - 65 years with American society of anesthesiology (ASA)class I - II.So that , Patients with hemodynamic instability or uncontrolled systemic,cardiac,respiratory,neurologic disorders would be excluded. Also, Allergy to soya or egg and patients who do not fill informed consent are excluded from the study. (5)Intervention: After injection different dosage of ketofol ,Ramsay sedation score will be assessed and in score below 3 ,additional half dose will be applied to reach the appropriate sedation depth. (6) Main outcome measures(Variables) : Severity of pain,Patients and Practitioners satisfaction ,recovery time and side effects are measured and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015111825121N1
Registration date: 2016-04-30, 1395/02/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-30, 1395/02/11
Registrant information
Name
Majid Ghodsipour
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4420 8212
Email address
majidghodsipour.em@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research ,Iran University of Medical Sciences
Expected recruitment start date
2015-12-15, 1394/09/24
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of different dosage of Ketofol for Procedural Sedation and Analgesia in the Emergency Department :a Randomized,Prospective,Double-Blind Trial
Public title
The Comparison of different dosage of ketamine - propofol ( ketofol ) for Procedural Sedation and Analgesia for Orthopedic injuries in Rasoul-Akram ,Hafte-Tir and Firouzgar Emergency Department:a Randomized,Prospective,Double-Blind Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient should be candidate for procedural sedation in ED;Patient should be in age range of 14 and 65 years;Patient should be with of 1 or 2 in physical status in American society anesthesiologist classification. Exclusion criteria : Pregnancy;Patients who have history of cardiovascular disease; Moderate to severe asthma attack; Present Pneumonia; Uncontrolled diabetes mellitus; Sepsis; Neurologic /Psychiatric disease:Using neurologic /psychiatric drugs; Moderate to severe obesity; cardiac; renal; liver; pulmonary insufficiency; Allergy to ketamine; propofol; soya; egg; Multiple trauma; Patients that do not fill consent form.
Age
From 14 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 256
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat freeway, next to Milad tower
City
Tehran
Postal code
Approval date
2015-12-14, 1394/09/23
Ethics committee reference number
9211307022

Health conditions studied

1

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

2

Description of health condition studied
Dislocation of elbow
ICD-10 code
S53.1
ICD-10 code description
Dislocation of elbow

3

Description of health condition studied
Dislocation of ankle joint
ICD-10 code
S93.0
ICD-10 code description
Dislocation of ankle joint

4

Description of health condition studied
Dislocation of hip
ICD-10 code
S73.0
ICD-10 code description
Dislocation of hip

5

Description of health condition studied
Multiple fracture of femor
ICD-10 code
S72.7
ICD-10 code description
Multiple fracture of femor

6

Description of health condition studied
Multiple fracture of lower leg
ICD-10 code
S82.3
ICD-10 code description
Multiple fracture of lower leg

7

Description of health condition studied
Multiple fracture of forearm
ICD-10 code
S52.7
ICD-10 code description
Multiple fracture of forearm

Primary outcomes

1

Description
Severity of Pain
Timepoint
Before and after procedure
Method of measurement
Visual analog scale

2

Description
Recovery time
Timepoint
From last drug prescription up to get needed criteria to leave the recovery
Method of measurement
Base on minute

3

Description
Sedation time
Timepoint
ّFrom first dose drug prescription up to get needed criteria to leave the recovery
Method of measurement
Base on minute

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before and during of procedure,during recovery and complete conscious time
Method of measurement
Checking blood pressure (non invasive)

2

Description
Heart rate
Timepoint
Before and during of procedure,during recovery and complete conscious time
Method of measurement
Checking the pulse for one minute

3

Description
Respiratory rate
Timepoint
Before and during of procedure,during recovery and complete conscious time
Method of measurement
Checking the RR for one minute

4

Description
Arterial oxygen saturation
Timepoint
Before and during of procedure,during recovery and complete conscious time
Method of measurement
Pulse oximetry monitoring

5

Description
Side effects of prescribed drugs
Timepoint
Before,during and after procedure
Method of measurement
Observation

6

Description
Patient's satisfaction
Timepoint
After procedure
Method of measurement
Base on Likert scale

7

Description
Practitioner's satisfaction
Timepoint
After procedure
Method of measurement
Base on Likert scale

Intervention groups

1

Description
Group A: A single dose of Propofol , 1 mg/kg ,IV as well as Ketamine 1 mg/kg , IV, 3 minute before the procedure .The next doses will be administered with half dose, or other sedative drugs ,if needed.
Category
Treatment - Drugs

2

Description
Group B: A single dose of Propofol , 1 mg/kg ,IV, plus Ketamine 0.5 mg/kg ,IV , 3 minute before the procedure.The next doses will be administered with half dose ,or other sedative drugs,if needed.
Category
Treatment - Drugs

3

Description
Group C: A single dose of Propofol, 1 mg/kg , IV , plus Ketamine 0.33 mg/kg ,IV , 3 minutes before the procedure.The next doses will be administered with half dose or other sedative drugs,if needed.
Category
Treatment - Drugs

4

Description
Group G: A single dose of Propofol , 1 mg/kg , IV, plus Ketamine , 0.25 mg/kg , IV, 3 minute before the procedure.The next doses will be administered with half dose,or other sedative drugs,if needed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul -Akram Hospital
Full name of responsible person
Dr. Saeed Abbasi
Street address
Rasoul-Akram Haspital, Niyayesh st. , Sattarkhan st.
City
Tehran

2

Recruitment center
Name of recruitment center
Haft-e-Tir Hospital
Full name of responsible person
Dr. Saeed Abbasi
Street address
Emam Khomeini Blvd , Shahr-e-Rey
City
Tehran

3

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Dr. Mahdi Rezai
Street address
Beh Afarin St, Karim Khan Zand Blvd, Valiasr Square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr.Naserbakht
Street address
Iran University of Medical sciences, Hemmat freeway, next to Milad tower
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Saeed Abbasi
Position
Associate Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences , Hemmat freeway, next to Milad tower
City
Tehran
Postal code
Phone
+98 21 6435 2197
Fax
Email
saeedabbasi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Saeed Abassi
Position
Associate Professor
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat freeway, next to Milad tower
City
Tehran
Postal code
Phone
+98 21 6435 2197
Fax
Email
saeedabbasi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Ghodsipour
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat freeway, next to Milad tower
City
Tehran
Postal code
Phone
00
Fax
Email
majidghodsipour.em@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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