1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effects sedation induced by fentanyl and remifentanil in patients under mechanical ventilation in the intensive care unit

Protocol summary

Summary
Objectives: Mechanical ventilation and inducing controlled sedation and analgesia with proper depth of anesthesia and the least complications is one the treatment goals in patients who are admitted to the intensive care unit. Because the cause of hospitalization and the physical condition of these patients is highly variable and often unstable, therefore recommending a unique standard model has not been achieved for all of them. In this study the level and also the side effects of fentanyl and remifentanil is compared. Design: Block randomization, without placebo, double center, trial phase 2, including 70 patients under mechanical ventilation. Participants including major eligibility criteria: All patients who are supposed to be under mechanical ventilation. Intervention: Remifentanil, 3 µg/kg/hr, intravenous injection. Fentanyl, 1 µg/kg/hr, intravenous injection. Main outcome measures: Sedation level, duration of ventilation, blood pressure, heart rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012311398N8
Registration date: 2015-02-06, 1393/11/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-06, 1393/11/17
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
m-ghodrati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects sedation induced by fentanyl and remifentanil in patients under mechanical ventilation in the intensive care unit
Public title
Comparison of the effects of anesthesia level of fentanyl and remifentanil in intensive care unit patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years old; Neurosurgical intensive care unit patients who need mechanical ventilation in the first 24 hours before or after neurosurgery; Stable hemodynamic. Exclusion criteria: Neuromuscular diseases; History of taking neuromuscular blocker medications; Pregnancy; Opium addiction.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
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

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
93 د/105/ 3348

Health conditions studied

1

Description of health condition studied
Mechanical ventilation
ICD-10 code
Z51.8
ICD-10 code description
Other specified medical care

Primary outcomes

1

Description
Sedation level
Timepoint
Every 2 hours in the first 6 hours and then every 6 hours since the first 24 hours
Method of measurement
Sedation scale

2

Description
Ventilation duration
Timepoint
Since ventilation to the time removing the device from the patient
Method of measurement
Chronometer

3

Description
Blood pressure
Timepoint
Every 2 hours in the first 6 hours and then every 6 hours since the first 24 hours
Method of measurement
Sphygmometer

4

Description
Heart rate
Timepoint
Every 2 hours in the first 6 hours and then every 6 hours since the first 24 hours
Method of measurement
Monitoring

Secondary outcomes

empty

Intervention groups

1

Description
Remifentanil, 3 µg/kg/hr, intravenous injection, made in Normon company, Spania.
Category
Treatment - Drugs

2

Description
Fentanyl, 1 µg/kg/hr, intravenous injection, made in Aboo-Reyhan company, Iran.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-e Akram hospital
Full name of responsible person
Fatemeh Sadat Mazhari
Street address
Rasool-e Akram hospital, Niyayesh street, Satarkhan street, Tehran, Iran
City
Tehran

2

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Fatemeh Sadat Mazhari
Street address
Firoozgar hospital, Firoozgar Hospital, Beh-afarin St. Karim Khan Av.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Headquarters building, 2nd floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, Vice Chancellor for Research
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
Fatemeh Sadat Mazhari
Position
Anesthesiology assistant
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
fmazhari.md@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Mazhari
Position
Anesthesiology assistant
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
fmazhari.md@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Mazhari
Position
Anesthesiology assistant
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
fmazhari.md@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
Loading...