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Compare the effects of low-dose combination of anesthetic drugs (including fentanyl, propofol, midazolam, ketamine and lidocaine) with the usual dose of propofol in creating deep sedation

Protocol summary

Summary
The aim of this study is to compare the effect of the anesthetic Low dose (including fentanyl, propofol, midazolam, ketamine and lidocaine) in deep sedation and its complications with the usual dose of propofol. The study is a single blind randomized clinical trial. In this study patients that require sedation in emergency department of Emam Hossein hospital, randomly are divided in two groups that first group is given low dose combination of anesthetic drugs including propofol in a dose of 0.5 miligram (mg) per kilogram of body weight, ketamine 0.2 to 0.25 mg per kilogram, midazolam 0.01 to 0.02 mg per kilogram, fentanyl 0.5 to 1 microgram per kilogram and lidocaine 0.5 to 1 mg per kilogram of body weight and second group is given propofol at a dose of 1 mg per kilogram and fentanyl 1 microgram per kilogram of body weight, and Its effects include the time required to create deep sedation , depth of sedation, the needed time for recovery, also effects of sedation, physician and patient satisfaction will be recorded. The total sample size is 122 patients (61 patients per group). Inclusion criteria: Patients admitted to the emergency department over 15 years to 60 years of age and they need PSA. Exclusion criteria: previous allergy to drugs used; sensitivity to egg or soy; Hemodynamic Instability; pregnancy; drug interactions; increased ICP.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112525235N1
Registration date: 2016-11-04, 1395/08/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-04, 1395/08/14
Registrant information
Name
Shahram Shokrzadeh
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 911 195 4119
Email address
a.amini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Reseach of Shahid Beheshti University of Medical Science
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of low-dose combination of anesthetic drugs (including fentanyl, propofol, midazolam, ketamine and lidocaine) with the usual dose of propofol in creating deep sedation
Public title
Comparison of anesthetic drugs to create deep sedation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients admitted to the emergency department of Emam Hossein hospital over 15 years to 60 years of age and they need Procedural sedation and analgesia (PSA) Exclusion criteria: previous allergy to drugs used in the study; sensitivity to egg or soy products; Hemodynamic Instability; pregnancy; drug interactions; increased intracranial pressure (ICP)
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were divided by blocked randomization method.

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Commitee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Science, Next to the Ayatollah Taleghani Hospital, Martyr Arabi Street, Yemen Street, Martyr Chamran highway, Tehran
City
Tehran
Postal code
198396-3113
Approval date
2015-02-15, 1393/11/26
Ethics committee reference number
sbmu.rec.13930717

Health conditions studied

1

Description of health condition studied
Procedural Sedation and Analgesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The needed time for recovery from deep sedation
Timepoint
Every 30 seconds since the beginning of deep sedation
Method of measurement
The interval time between induction of sedation (Ramsay score 6) and recovery (Ramsy score of 2

2

Description
The depth of sedation
Timepoint
Every 30 seconds since the beginning of sedation
Method of measurement
the depth of sedation according to the Ramsay score

3

Description
The time required to create deep sedation
Timepoint
Every 30 seconds
Method of measurement
Since the beginning of sedative drugs to achieve deep sedation (Ramsay score equal to 6)

Secondary outcomes

1

Description
Cardiac arrhythmia
Timepoint
continuously since the beginning of sedation
Method of measurement
Cardiac monitoring

2

Description
Arterial blood pressure
Timepoint
Before prescription of drugs, then every 5 minutes until recovery time
Method of measurement
Using the sphygmomanometer

3

Description
physician and patient's satisfaction
Timepoint
after the procedure
Method of measurement
By questionnaire

4

Description
Arterial blood oxygen saturation
Timepoint
Continuously since the beginning of sedation
Method of measurement
Pulse oximetry

5

Description
Vomiting
Timepoint
since the beginning of sedation until full recovery
Method of measurement
Observation

Intervention groups

1

Description
Intervention group: Intervention group patients are given low doses of sedative drugs, including propofol in a dose of 0.5 mg per kilogram of body weight, ketamine 0.2 to 0.25 mg per kilogram of body weight, midazolam at doses of 0.01 to 0.02 mg per kilogram of body weight, fentanyl 0.5 to 1 microgram per kg of body weight and lidocaine 0.5 to 1 mg per kilogram of body weight Intravenously .
Category
Treatment - Drugs

2

Description
Control group: patients in control group are given propofol at a dose of 1 mg per kilogram and fentanyl 1 microgram per kilogram of body weight Intravenously .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hossein hospital, Tehran
Full name of responsible person
Shahram Shokrzadeh.MD
Street address
Emam Hossein Hospital, Shahid madani ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Reseach of Shahid Beheshti University of Medical Science
Full name of responsible person
Shahram Shokrzadeh
Street address
Shahid Beheshti University of Medical Science, Next to the Ayatollah Taleghani Hospital, Martyr Arabi Street, Yemen Street, Martyr 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 Reseach of Shahid Beheshti University of Medical Science
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 Science
Full name of responsible person
Shahram Shokrzadeh.MD
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Emam Hossein Hospital, Shahid Madani Ave, Tehran
City
Tehran
Postal code
-
Phone
+98 21 73430
Fax
+98 21 7755 7069
Email
shahram.shokrzadeh@gmail.com
Web page address
ehmc.sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical science
Full name of responsible person
Afshin Amini . MD
Position
Asisstant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Emam Hossein Hospital, Shahid Madani Ave, Tehran, Iran
City
Tehran
Postal code
-
Phone
+98 21 73430
Fax
+98 21 7755 7069
Email
a.amini@sbmu.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Shahram Shokrzadeh.MD
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Emam Hossein Hospital, Shahid Madani Ave, Tehran
City
Tehran
Postal code
-
Phone
+98 21 73430
Fax
+98 21 7755 7069
Email
shahram.shokrzadeh@gmail.com
Web page address
ehmc.sbmu.ac.ir

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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