Protocol summary

Summary
Objectives: Recovery units in the operating rooms perform a part of the work done in the post anesthesia care unit since the patients transfer to the relative ward after stabilization of cardiovascular and respiratory state, maintaining full consciousness, and ability to move limbs. Discharge rate of these patients and the sustainability of organs can vary depending on the type of anesthesia and used drugs and affects discharge of patients from recovery. To improve hemodynamic parameters and consciousness of patients undergoing posterior lumbar spine fusion surgery, we compare two combinations include dexmedetomidine and propofol versus remifentanil and propofol. Design: Block randomization, double blind, without placebo, single center, trial phase 2, including 20 patients who undergo posterior lumbar spine fusion surgery. Setting and conduct: Fentanyl, 2 μg/kg, intravenous, to induce anesthesia. Atracurium, 0.2 mg/kg, intravenous, to induce anesthesia. Participants including major eligibility criteria: All women who are supposed to undergo posterior lumbar spine fusion surgery. Intervention: Dexmedetomidine, 0.1 μg/kg, intravenous. Remifentanil, 1 μg/kg, intravenous. Propofol, 2 mg/kg, intravenous, to induce anesthesia. Main outcome measures: Activity level, Respiration, Consciousness, Blood pressure, O2 saturation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102819715N1
Registration date: 2014-12-24, 1393/10/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-24, 1393/10/03
Registrant information
Name
Arash Pourbakhshandeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
alimyan.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of dexmedetomidine and propofol versus remifentanil and propofol on rate of discharge from recovery in patients candidate for posterior lumbar spine fusion surgery
Public title
Comparison of dexmedetomidine versus remifentanil on rate of discharge from recovery in patients candidate for posterior lumbar spine fusion surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patient satisfaction; Age between 18-65 years old; Patients candidate for posterior lumbar spine fusion surgery; Elective surgery; No history of spinal surgery. Exclusion criteria: Addiction to drugs or alcohol; Sensitivity to drugs use in this study; Long-term and chronic use of painkillers; Respiratory and cardiovascular diseases; Unpredictable events such as severe bleeding.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
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
2013-10-29, 1392/08/07
Ethics committee reference number
92/130/1640

Health conditions studied

1

Description of health condition studied
Fusion of spine
ICD-10 code
M43.8
ICD-10 code description
Other specified deforming dorsopathies

Primary outcomes

1

Description
Activity level
Timepoint
Every ten minutes after extubation
Method of measurement
Aldrete score

2

Description
Respiration
Timepoint
Every ten minutes after extubation
Method of measurement
Aldrete score

3

Description
Consciousness
Timepoint
Every ten minutes after extubation
Method of measurement
Aldrete score

Secondary outcomes

1

Description
Blood pressure
Timepoint
Every ten minutes after extubation
Method of measurement
Sphygmometer

2

Description
O2 saturation
Timepoint
Every ten minutes after extubation
Method of measurement
Pulse oximeter

Intervention groups

1

Description
Intervention 1. Dexmedetomidine, 0.1 μg/kg, intravenous.
Category
Treatment - Drugs

2

Description
Intervention 2. Remifentanil, 1 μg/kg, intravenous.
Category
Treatment - Drugs

Recruitment centers

1

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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Headquarters building, 5th 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
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
Arash Pourbakhshandeh
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 6435 2326
Fax
Email
Dr.pourbakhshandeh@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
Arash Pourbakhshandeh
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 6435 2326
Fax
Email
Dr.pourbakhshandeh@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
Arash Pourbakhshandeh
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
00
Fax
Email
Dr.pourbakhshandeh@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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