Protocol summary

Summary
Eighty seven patients undergoing elective spine surgery with device are studied. The study examined patients in three groups of each 30 in A, B, C groups in a double-blind Randomized Clinical Trial. Exclusion criteria: acute or chronic renal failure; liver failure; nerve paralysis (Hemiplegia); spinal nerve injury; COPD (chronic obstructive pulmonary disease) and patient dissatisfaction. Moreover, patients addicted to drugs, alcohol or other drugs do not include in the study. All patients or their guardians consent to be in the study and there is no obligations. Essential training about the standard visual analogue scale (VAS) is taught to patients in which the VAS shows to the patient marked 0-10 and 0 means No Pain and number 10 shows the Worst pain unbearable. Furthermore, to all patients Pulse oximeter, Non Invasive and Invasive blood pressure, end-tidal CO2 and temperature monitoring are given in the operation room. BIS monitoring is performed for all patients. After preoxygenation with facial mask and premedication with Midazolam 0.03 mg/kg and 1-3 microgram /kg Fentanyl patients will anesthetized by Propofol 2 Mg/Kg and Atracurium 0.5 mg/kg; moreover, after 3 minutes patient will intubate with tracheal tube. Anethesiologist and surgery team is the same for all patients. For maitenance propofol 100-150 microgram\kg\hr and Atracurium 0.2 mg per every 30 minutes is used. The analgesia for Group A Fetanyl and for group B and C Remifentanil is used. Moreover, at the end of 20 minutes of surgery, Apotel 15 mg\kg is used for group A and B but in group C is morphine 0.05 mg\kg. 30 minutes after patients stay at recovery room, 6, 12, 24, 48 after surgery vital signs, Visual Analouge Scale, Ramsey Sedation Score and the absence of existence of Post Operation Vomiting and nausea and Respiratory depression due to the prescribing morphine will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014072618597N1
Registration date: 2015-03-12, 1393/12/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-12, 1393/12/21
Registrant information
Name
Reza Shariat Moharari
Name of organization / entity
Sina Hospital
Country
Iran (Islamic Republic of)
Phone
+98 911 331 2758
Email address
moharari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Obtainability of intraoperative remifentanil infusion induced hyperagesia and compare control methods of post op pain with Morphine or Apotel.
Public title
Obtainability of intraoperative remifentanil infusion induced hyperalgesia and compare control methods pf post op pain with Morphine or Apotel.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients between the age of 15-75; with ASA class I or II. Exclusion criteria: patients with acute kidney failure; chronic kidney failure; hepatic dysfunction; patients addicted to drugs; alcohol and other medications.
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 87
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
Tehran University of Medical Sciences
Street address
Tehran University Of Medical Sciences, Taleghani St, Enghelab Sq, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-12-06, 1393/09/15
Ethics committee reference number
92-04-30-27234-132500

Health conditions studied

1

Description of health condition studied
Patients undergoing spinal surgery in which device will be used
ICD-10 code
M47-M48
ICD-10 code description
Spondylosis and Other spondylopathies

Primary outcomes

1

Description
Pain
Timepoint
At Recovery Room, 6, 12, 24,48 hours after surgery
Method of measurement
Visual Analogue Scale

2

Description
Ramsey Sedation Scale
Timepoint
Recovery, 6, 12, 24,48 hours after surgery
Method of measurement
Ramsey Sedation Score Table

3

Description
Morphine consumption after surgery
Timepoint
Recovery, 6, 12, 24,48 hours after surgery
Method of measurement
Milligram

Secondary outcomes

1

Description
Respiratory Depression
Timepoint
At Recovery Room, 6,12,24,48 hrs. after surgery
Method of measurement
Clinical Observation

2

Description
Post Operation Vomiting and Nausea (PONV)
Timepoint
At Recovery Room, 6,12,24,48 hrs. after surgery
Method of measurement
Standard Scale

Intervention groups

1

Description
Group I : Remifentanil ( maintenance) and Apotel ( end of surgery) According Methods
Category
Treatment - Drugs

2

Description
Group II : Remifentanil ( maintenance) , Morphine ( end of surgery) According Methods
Category
Treatment - Drugs

3

Description
Group III : Fentanyl ( maintenance) Apotel ( end of surgery) According Methods
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Reza Shariat Moharari
Street address
Sina Hospital, Hassan Abad Sq, Imam Khomeini St, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Reza Shariat Moharari
Street address
Taleghani St, Qods St, Enghlab Sq, 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
Tehran 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
Sina Hospital
Full name of responsible person
Elahe sahraei
Position
Anesthesia Student
Other areas of specialty/work
Street address
Sina Hospital, Imam khomeini St, Imam khomeini Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 919 550 5701
Fax
Email
e.sahrai@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr. Reza Shariat Moharari
Position
Associate Proffesor-Anesthesiologist
Other areas of specialty/work
Street address
Sina Hospital, Imam khomeini St, Hassan Abad Sq, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6634 8533
Fax
Email
moharari@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Elahe Sahraei
Position
Anesthesia student
Other areas of specialty/work
Street address
Sina Hospital, Hassan Abad Sq, Imam Khomeini St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 919 550 5701
Fax
Email
e.sahrai@ymail.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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