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Comparison of Two Different Doses of Ketamine on byspectral index, hemodynamic changes and mental status of patients undergone on closed nasal bone manipulation operation

Protocol summary

Summary
ketamine is a non barbiturates short acting intravenous anesthetic drug that caused the separative anesthesia like involuntary movements and cataleptic mode. In older patients ketamin is beneficial in emergency trauma and surgery or shock. To determine the efficacy of two doses of ketamine on the byspectral index, hemodynamic changes and mental status of patients undergoing reduction of nasal fracture surgery. A clinical trial study on 80 patients’ candidate for closed reduction of nasal fracture surgery, 18 to 59 years old who classified in Class 1 ASA anesthesia is used. People with history of hypertension, epilepsy, hyperthyroid, mental disorders coronary artery were excluded. This form of random allocation was designed to block randomization, in both group, At first, was administered 0.1 mg/kg Sufentanil then 0.2mg/kg Midazolam after that, in control group, anesthetic induction in Group HDK (High Dose Ketamin)was pretreated with ketamine 1 mg/kg and in intervention group, anesthetic induction in Group LDK(Low Dose Ketamin) was pretreated with ketammin 0.5mg/kg. Patient during, exactly after induction by ketamin and after the operation every 15 minutes until 2 hours for efficacy of anesthesia and hemodynamic changes by blood pressure measurement with same manometer, heart rate, BSI (with superficial electrodes on head skin were performed by the same nurse who was blinded to Study medication.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012080710471N2
Registration date: 2012-09-17, 1391/06/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-17, 1391/06/27
Registrant information
Name
Milad Masaeli
Name of organization / entity
Kurdistan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3356 5240
Email address
drmilmas@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdestan University of Medical Science
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Two Different Doses of Ketamine on byspectral index, hemodynamic changes and mental status of patients undergone on closed nasal bone manipulation operation
Public title
Efficacy of Ketamin on efficiency of anasthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion critria: ASA class I;18-60 years of age;patients undergoing elective closed manipulation operation. Exclusion critria:neurological disorders; a negative effect in communication;history of hypersensitivity towards these drugs; hypertension; epilepsy; hyperthyroidism; psychological disorders; cardiovascular disease; opium addiction.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Kurdestan Local Research Ethics Committee
Street address
Kurdestan University of Medical Science, Pasdaran ave, Azadi sqare
City
Sanandaj
Postal code
Approval date
2010-03-18, 1388/12/27
Ethics committee reference number
پ14پ11961

Health conditions studied

1

Description of health condition studied
Anasthetic Unspecified
ICD-10 code
Y-48.4
ICD-10 code description
Anasthetic Unspecified

Primary outcomes

1

Description
Blood Preasure
Timepoint
during,exactly after induction by ketamin, after the operation every 15 minutes till 2 hours
Method of measurement
blood pressure measurement with same manometer were performed by the same nurse who was blinded to Study medication.

2

Description
Heart Rate
Timepoint
during,exactly after induction by ketamin, after the operation every 15 minutes till 2 hours
Method of measurement
Radial pulse was performed by the same nurse who was blinded to Study medication.

3

Description
BSI
Timepoint
during,exactly after induction by ketamin, after the operation every 15 minutes till 2 hours
Method of measurement
BSI by superfisial electrodes on the head skin.it was explained as an index between 0-100 was performed by the same nurse who was blinded to Study medication.

Secondary outcomes

empty

Intervention groups

1

Description
in intervention group, At first was administered 0.1 mg/kg Sufentanil then 0.2mg/kg Midazolam and at last anesthetic induction with ketammin 0.5mg/kg.
Category
Treatment - Drugs

2

Description
in control group,At first was administered 0.1 mg/kg Sufentanil then 0.2mg/kg Midazolam and at last anesthetic induction ketamine 1 mg/kg.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Toohid Hospital
Full name of responsible person
Milad Masaeli
Street address
City
Snandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdestan University of Medical Science
Full name of responsible person
Fardin Gharibi
Street address
Kurdestan University of Medical Sience, Pasdaran avenue,Azadi sqare
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdestan 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
Student of Research Committee, Kurdistan University of Medical Sciences
Full name of responsible person
Milad Masaeli
Position
Student research committee of Kurdestan University of Medical Sience
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
Phone
+98 87 1662 9246
Fax
Email
drmilmas@muk.ac.irdrmilmas@gmail.comdrmilmas@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Assistant Professor of Anesthesiology ,Department of Anesthesia, Beesat Hospital, Kurdistan Universi
Full name of responsible person
Negin Ghadami
Position
Anesthetiology
Other areas of specialty/work
Street address
Department of Anesthesia, Beesat Hospital, Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 1662 9246
Fax
Email
narin_narini@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student Research Committee, Kurdistan University of Medical Sciences
Full name of responsible person
Milad Masaeli
Position
Other areas of specialty/work
Street address
Kurdestan University of Medical Sience, Pasdaran Ave, Azadi Square,
City
Sanandaj
Postal code
Phone
00
Fax
Email
drmilmas@muk.ac.ir
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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