Comparative Evaluation of Ketamine-Fentanyl and Propofol-Fentanyl on Hemodynamic Changes of Laryngeal Mask Airway Insertion and Post Anesthesia Complications in Inguinal Herniorrhaphy Surgery
To compare the effects of Propofol-Fentanyl and Ketamine-Fentanyl on hemodynamic changes during Laryngeal Mask Airway insertion and post anesthesia complications in Inguinal Herniorrhaphy surgery, in a clinical trial, 120 patients aged 16 to 70 who are candidate for Herniorrhaphy surgery are included. The patients are randomly divided in two groups: Group A (Ketamine-Fentany) and Group B (Propofol-Fentanyl). In group A Fentanyl 3 µ/kg and Ketamine 2 mg/kg, and in group B Fentanyl 3 µ/kg and Propofol 2 mg/kg, will be intravenously injected, then an appropriate Laryngeal Mask Airway will be inserted. Anesthesia will be continued in both groups using mechanical ventilation with 50 % N2O - 50% O2 and Isoflurane 1.2%. Heart Rate and Blood Pressure, will be recorded before the induction of anesthesia and insertion of Laryngeal Mask Airway, and 1, 3, 5 and 10 minutes after it. Duration of surgery and recovery, agitation, nausea and vomiting will also be recorded in order to compare between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070618375N1
Registration date:2014-09-14, 1393/06/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-14, 1393/06/23
Registrant information
Name
Mohamad Hajijafari
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
dr_hajijafari@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
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
Comparative Evaluation of Ketamine-Fentanyl and Propofol-Fentanyl on Hemodynamic Changes of Laryngeal Mask Airway Insertion and Post Anesthesia Complications in Inguinal Herniorrhaphy Surgery
Public title
Comparing the effects of Ketamine-Fentanyl and Propofol-Fentanyl on Anesthesia Process
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients who are candidate for Herniorrhaphy surgery
Exclusion Criteria: Hemodynamic instability; History of psychotic disorder; Brain injury or intracranial lesion; ASA class 3 or more; History of reaction to anesthetic drugs
Age
From 16 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Panzdah Khordad Square, Kashan
City
Kashan
Postal code
Approval date
2014-06-11, 1393/03/21
Ethics committee reference number
1474
Health conditions studied
1
Description of health condition studied
Hemodynamic changes during insertion of Laryngeal Mask Airway and post anesthesia complications after using Ketamine-Fentanyl and Propofol-Fentanyl
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Vomiting
Timepoint
During the recovery
Method of measurement
Observation
2
Description
Agitation
Timepoint
During the recovery
Method of measurement
Richmond Agitation Sedation Scale (RASS)
3
Description
Heart Rate
Timepoint
1, 3, 5, 10 min
Method of measurement
Beat per minute
4
Description
Blood Pressure
Timepoint
1, 3, 5, 10 min
Method of measurement
mm Hg
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Fentanyl 3 µ/kg and after 3 minutes Ketamine 2 mg/kg, Atrachorium 0.3 mg/kg is intravenously injected and after 3 minutes appropriate Laryngeal Mask Airway is inserted.
Category
Treatment - Drugs
2
Description
Control Group: Fentanyl 3 µ/kg and after 3 minutes Propofol 2 mg/kg, Atrachorium 0.3 mg/kg is injected and after 3 minutes appropriate Laryngeal Mask Airway is inserted.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Mohammad Hajijafari
Street address
Ravand Boulevard
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidi
Street address
Ravand Boulevard
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Hajijafari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ravand Boulevard
City
Kashan
Postal code
Phone
+98 31 5533 9292
Fax
Email
dr_hajijafari@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Hajijafari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ravand Boulevard
City
Kashan
Postal code
Phone
+98 31 5533 9292
Fax
Email
dr_hajijafari@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Hajijafari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ravand Boulevard
City
Kashan
Postal code
Phone
+98 31 5533 9292
Fax
Email
dr_hajijafari@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)