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Comparison of with and without preoxygenation methods in patients needed procedural sedation and anesthesia with ketamine and propofol in Sina Hospital's emergency department

Protocol summary

Study aim
Compare with and without preoxygenation methods in patients requiring procedural sedation and anesthesia with ketamine and propofol. comparison of ETCo2 changes .comparison of blood pressure changes, comparison of heart rate changes, comparison of apnea rate in two groups.
Design
The randomized clinical trial study, patients are randomized based on computer generated table. The researchers, patients, and patient's care giver are blind. Phase 3 studies are performed on 126 patients.
Settings and conduct
Sina Hospital Emergency Department; Participants, patient's care giver, and procedures performer are blinded.The patient is given oxygen or air with a plain mask for 5 minutes immediately before PSA. Oxygen saturation, ETCO2, vital signs, and possible complications are recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients required procedural sedation and anesthesia in the ED. Exclusion criteria: very old or very young patients; Pregnant; History of ischemic or congestive heart disease; restrictive or obstructive lung disease; oxygen saturation less than 92% at rest; allergy history to egg, Propofol or Ketamine; SBP more than 180 or less than 90 mmHg; patients who do not tend to participate in the study; patients who are unable to sign consent.
Intervention groups
In one group, oxygen and in the other group, air is administered via a simple mask, both for 5 minutes and with a flow of 6 liters per minute. Oxygen saturation, ETCO2, vital signs and possible complications are recorded.
Main outcome variables
Hypoxia, which is based on capnographic information and the disappearance of the capnographic wave as well as the decrease of oxygen saturation to less than 90% with a pulse oximeter. Other variables include decreased heart rate, hypotension, and side effects of medications such as nausea, prolonged sleep.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210724051964N1
Registration date: 2021-09-13, 1400/06/22
Registration timing: retrospective

Last update: 2021-09-13, 1400/06/22
Update count: 0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Alireza Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1432
Email address
ajalali@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of with and without preoxygenation methods in patients needed procedural sedation and anesthesia with ketamine and propofol in Sina Hospital's emergency department
Public title
Comparison of with and without preoxygenation methods in patients needed procedural sedation and anesthesia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients needed procedural sedation and anesthesia in ED
Exclusion criteria:
Age < 19 Age >65 Pregnant patients History of ischemic heart disease and Congestive heart disease History of restrictive or obstructive lung disease Oxygen saturation less than 92% at rest Allergy history to egg Allergy history to Ketamine or Propofol Systolic blood pressure more than 180 or less than 90 mmhg before procedure Patients who did not tend to participate in the study Patients who are unable to sign consent
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by coding via Randomization software by a blinded person to research
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient, the patient monitor, and the procedure performer are blinded to the patient group. One of the researchers, who is not involved in the diagnosis and analysis of the study, performs blinding of oxygen capsules as a pair and an individual.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran university of Medical Sciences
Street address
Sina hospital, Imam khomeini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
1399.049.IR.TUMS.SINAHOSPITAL.REC

Health conditions studied

1

Description of health condition studied
Preoxygenation in patients required sedation and anesthesia in ED
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Decreased oxygen saturation, which includes the disappearance of the capnograph wave or the drop in oxygen saturation measured by the pulse oximeter.
Timepoint
At the beginning, 10, 20 and 30 min after administration of oxygen or air
Method of measurement
Using capnography and pulse oximerty.

Secondary outcomes

1

Description
Decreasing in blood pressure more than 10% of patient's basic blood pressure
Timepoint
At the beginning , 10 , 20 and 30 minutes after prescription of oxygen or air
Method of measurement
By Blood pressure cuff measurement of monitors

2

Description
Variation of end tidal Co2
Timepoint
At the beginning , 10 , 20 and 30 minutes after prescription of oxygen or air
Method of measurement
By Capnograph

3

Description
Heart rate decreasing
Timepoint
At the beginning , 10 , 20 and 30 minutes after prescription of oxygen or air
Method of measurement
By monitor at the bedside

4

Description
Apnea occurrence
Timepoint
At the beginning , 10 , 20 and 30 minutes after prescription of oxygen or air
Method of measurement
By Capnography and pulse oximetry

Intervention groups

1

Description
Intervention group: Air prescription in patients required sedation and anesthesia
Category
Other

2

Description
Control group: Oxygen prescription in patients required anesthesia in ED.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Alireza Jalali
Street address
Sina hospital, Imam khomeini St.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Email
ajalali@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadali Sahraian
Street address
Deputy of research and technology, Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 9863
Email
tums_res@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Jalali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sina Hospital, Imam Khomeini St.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1432
Email
ajalali@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Jalali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sina Hospital, Imam Khomeini St.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1432
Email
ajalali@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Jalali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sina hospital., Imam Khomeini St.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1432
Fax
+98 21 6312 1432
Email
ajalali@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Base information of the participants in the study, information the main outcome and possible side effects
When the data will become available and for how long
Starting instantly after publication
To whom data/document is available
Only available for people working in academic institution
Under which criteria data/document could be used
Any analysis is allowed
From where data/document is obtainable
Contact with ajalali@sina.tums.ac.ir
What processes are involved for a request to access data/document
Contact with ajalali@sina.tums.ac.ir
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