Protocol summary

Summary
1) Objectives :Clinical Trial of The Effect of Low Dose Ketamine on Blood Pressure During Positioning After Induction of Anesthesia in Patients Undergoing Lumbar Discectomy ,Clinical Trial of The Effect of Placebo on Blood Pressure During Positioning After Induction of Anesthesia in Patients Undergoing Lumbar Discectomy , Comparison of the Blood Pressure Reduction after Induction of Anesthesia in Two Groups 2) Design: Patients Undergoing Lumbar Discectomy , in Two Groups Ketamine and Placebo , 42 Patient in each Group , Double Blind , Single Center, Recruiting, Randomisation by Random number tables, 3) Setting and conduct: Induction in All Patients will be simillar including Midazolam 0.03 mg/kg, Fentanyl 2 micg/kg, Propofol 1 to 2.5 mg/kg and Atracurium 0.5 mg/kg . After Induction and Intubation, in Ketamine Group 0.5 mg/kg and in Placebo Group Normal Saline with the same volume will be injected . After 90 Seconds to reach the Peak Effect of Ketamine All the Patients with a similar technique will be Positioned. Systolic , Diastolic and Mean Arterial Blood Pressure will be recorded Preoperative , Pre Intubation , one minute after Intubation , before Positioning , Immediately after Positioning the Patient from Supine to Prone Position , then every 2 minute until 10 minutes after Positioning . In the Case of Hypotention more than 20 percent Ephedrine 5 mg ( Heart Rate Less than 100/min ) or Phenylephrine 50 to 100 microgram ( Heart Rate more than 100/min ) will be used . 4) Participants Inclusion Criteria: Patients candidated for Lumbar Discectomy, Age between 20 to 40 year with ASA(American Society of Anesthesiologists) Class I, Exclusion Criteria: History of Cardiovascular Drugs usage, Emergency Procedures, Body Mass Index more than 40. 5) Intervention: 1- Midazolam 0.03 mg/kg, Fentanyl 2 micg/kg, Propofol 1 to 2.5 mg/kg and Atracurium 0.5 mg/kg and Endotracheal Intubation , Ketamine 0.5 mg/kg 1.5 minutes before Positioning The Patient from Supine to Prone Position , 2- Midazolam 0.03 mg/kg, Fentanyl 2 micg/kg, Propofol 1 to 2.5 mg/kg and Atracurium 0.5 mg/kg and Endotracheal Intubation , Placebo with the same volume (Normal Saline ) 1.5 minutes before Positioning The Patient from Supine to Prone Position , 6) main outcome measures: Blood Pressure changes

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062726328N2
Registration date: 2016-08-25, 1395/06/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-25, 1395/06/04
Registrant information
Name
Masoud Parish
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 5842
Email address
parishm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of The Effect of Low Dose Ketamine to Prevent Hypotension While Changing Position After Induction of Anesthesia in Patients Undergoing Lumbar Discectomy
Public title
The effect of Low –dose ketamine to prevent hypotension due to positioning after induction of general anesthesia in lumbar discectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Patients candidated for Lumbar Discectomy, Age between 20 to 40 year with ASA(American Society of Anesthesiologists) Class I, Exclusion Criteria: History of Cardiovascular Drugs usage, Emergency Procedures, Body Mass Index more than 40
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random Number Table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Shohada Hospital, Yaghchian, Golshahr Avenue, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
IR.TBZMED.REC.1395.234

Health conditions studied

1

Description of health condition studied
Hypotension
ICD-10 code
I95.2
ICD-10 code description
Complications of medical and surgical care

Primary outcomes

1

Description
Diastolic Blood Pressure
Timepoint
Preoperative , Pre Intubation , one minute after Intubation , before Positioning , Immediately after Positioning the Patient from Supine to Prone Position , then every 2 minute until 10 minutes after Positioning
Method of measurement
mmHg using Non Invasive Blood Pressure Technique by Monitoring Device

2

Description
Mean Arterial Pressure
Timepoint
Preoperative , Pre Intubation , one minute after Intubation , before Positioning , Immediately after Positioning the Patient from Supine to Prone Position , then every 2 minute until 10 minutes after Positioning
Method of measurement
mmHg using Non Invasive Blood Pressure Technique by Monitoring Device

3

Description
Systolic Blood Pressure
Timepoint
Preoperative , Pre Intubation , one minute after Intubation , before Positioning , Immediately after Positioning the Patient from Supine to Prone Position , then every 2 minute until 10 minutes after Positioning
Method of measurement
mmHg using Non Invasive Blood Pressure Technique by Monitoring Device

4

Description
Heart Rate
Timepoint
Preoperative , Pre Intubation , one minute after Intubation , before Positioning , Immediately after Positioning the Patient from Supine to Prone Position , then every 2 minute until 10 minutes after Positioning
Method of measurement
Beat/min

Secondary outcomes

empty

Intervention groups

1

Description
Intervention by drug includes ketamine 0.5 mg/kg 1.5 minutes before positioning of the patient from supine to prone
Category
Treatment - Drugs

2

Description
In control group Normal Saline with the same volume will be used 1.5 minutes before positioning of the patient from supine to prone position
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Parish Masoud
Street address
Shohada Hospital, Golghasht Avenue, Yaghchian, Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Parish Masoud
Street address
Shohada Hospital, Golshahr Avenue, Yaghchian, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Parish Masoud
Position
Anesthesiologist/Associate Professor
Other areas of specialty/work
Street address
Shohada Hospital, Golshahr Avenue, Yaghchian, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parishm@tbzmed.ac.ir; masoudparish@yahoo.com; artin1393.ap@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parish Masoud
Position
Anesthesiologist/Associate Professor
Other areas of specialty/work
Street address
Shohada Hospital, Golshahr Avenue, Yaghchian, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parishm@tbzmed.ac.ir; masoudparish@yahoo.com; artin1393.ap@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parish Masoud
Position
Anesthesiologist/Associate Professor
Other areas of specialty/work
Street address
Shohada Hospital, Golshahr Avenue, Yaghchian, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parishm@tbzmed.ac.ir; masoudparish@yahoo.com; artin1393.ap@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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