In a double-blind clinical trial study involving women referred to Imam Khomeini Hospital, Ahwaz, Iran for hysteroscopy are randomly divided into two groups of 20. Induction of anesthesia in a group with propofol and the other group receive ketofol (ketamine and propofol). Vital signs including systolic blood pressure, heart rate, expiratory carbon dioxide levels, the depth of anesthesia and the incidence of apnea before and after drug administration are measured and the incidence of patient’s complications in the recovery and the recovery time are compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105176510N1
Registration date:2012-02-14, 1390/11/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-14, 1390/11/25
Registrant information
Name
Seyed Amin Mousavian Roshanzamir
Name of organization / entity
Joundishapour Ahwaz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1332 3834
Email address
roshanzamir.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jondishapour University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2011-10-22, 1390/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of Propofol with ketofol (a Ketamine-Propofol combination) for sedation during hysteroscopy in patient in IVF operation room
Public title
A comparison of Propofol with ketofol (a Ketamine-Propofol combination) for sedation during hysteroscopy in patient in IVF operation room
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age under 40y, ASA class 1&2, no cardiovascular risk factor, no history of reaction to egg or soy bean & Ketamine or propofol, no psychiatric history, no history of airway difficulty. Exclusion criteria: airway difficulty like difficult ventilation, change of hysteroscopy to open surgery or complicated hysteroscopy.
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jondishapour University of Medical Sciences
Street address
Golestan Boulevard
City
Ahwaz
Postal code
12335645
Approval date
2011-07-27, 1390/05/05
Ethics committee reference number
Eth196
Health conditions studied
1
Description of health condition studied
Parenteral anaesthetics
ICD-10 code
Y48.1
ICD-10 code description
Parenteral anaesthetics
Primary outcomes
1
Description
Depth of anesthesia
Timepoint
5 minute after induction of anesthesia
Method of measurement
with Bispecteral Index Score device
Secondary outcomes
1
Description
Incidence of apnea
Timepoint
in time of anesthesia
Method of measurement
observation of anesthesiologist
2
Description
Incidence of nausea & vomiting
Timepoint
in time of anesthesia & recovery
Method of measurement
observation of anesthesiologist
3
Description
Systolic blood pressure
Timepoint
before & 5 minute after induction of anesthesia
Method of measurement
automatic blood pressure device
4
Description
Pulse rate
Timepoint
before & 5 minute after induction of anesthesia
Method of measurement
ECG monitoring device
5
Description
psychiatric side effect
Timepoint
recovery period
Method of measurement
observation of anesthesiologist
Intervention groups
1
Description
Intervention group: combination of ketamine and propofol to 5mg/kg of each drugs that inject to patients to 1 mg/kg of propofol.
Category
Treatment - Drugs
2
Description
Control group: combination of propofol with sterile water to 5mg/kg of propofol that inject to patients to 1 mg/kg of propofol.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
IVF ward, Ahwaz Imam Khomeini Hospital
Full name of responsible person
Khoshnud, Saeideh
Street address
Imam Khomeini Hospital
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jondi Shapur University of medical sciences
Full name of responsible person
Feghi Mostafa
Street address
Golestan Boulevard
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jondi Shapur 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
Ahwaz Jondi Shapour University of medical sciences
Full name of responsible person
Seyed Amin Mousavian Roshan Zamir
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Ward, Imam Khomeini Ahwaz Hospital
City
Ahwaz
Postal code
12335645
Phone
+98 61 1222 2114
Fax
+98 61 1222 0168
Email
amin_vw@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondi Shapur University of medical sciences
Full name of responsible person
Beh Aein Kaveh
Position
anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology ward, Imam Khomeini Ahwaz Hospital
City
Ahwaz
Postal code
12335645
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
drbehaeen@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jondi Shapur University of medical sciences
Full name of responsible person
Seyed Amin Mousavian Roshan Zamir
Position
Resident of anesthesiolgy
Other areas of specialty/work
Street address
anesthesiology ward, Ahwaz Imam Khomeini Hospital
City
Ahwaz
Postal code
12335645
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
amin.vw@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)