Comparison of the effect of ketofol with dexmedetomidine on anesthesia in patients undergoing dilatation and curettage
Design
The study will be a controlled intervention that is non-random and blinded. Sample size included 150 patients with dilatation and curettage.
Settings and conduct
The study will be performed on patients who are candidates for dilatation and curettage who will be referred to Alavi Hospital in Ardabil. The patients will be divided into 3 groups described and will be monitored in all three groups after the patient enters the operating room. Then an appropriate venous route is established and primary hydration will be performed. Oxygen will be provided with a mask for all patients. Then, any hemodynamic changes or respiratory disorders including apnea or hypoventilation and suction loss and need for respiratory support and recovery time will be recorded in all three groups. Randomization and blinding were not observed in the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 16 years of age, candidates for dilatation and curettage with grade 1 and 2 ASA, and consent to participate in the study.
Exclusion criteria: A history of allergy to propofol and other injectable anesthetics, drug abusers, alcohol and psychotropic drugs, hypertension.
Intervention groups
The first group received ketofol at the ratio of ketamine (0.5 mg / kg) to propofol (1 mg / kg), the second group dexmedetomidine at a dose of 1 mg / kg / stat for 10 minutes, then 1 µg / kg / h and the third group received propofol at a dose of 1 mg / kg. 1 kg and then isoflurane 1% will be prescribed for patients
Main outcome variables
The incidence of apnea during anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191022045203N1
Registration date:2019-11-14, 1398/08/23
Registration timing:registered_while_recruiting
Last update:2019-11-14, 1398/08/23
Update count:0
Registration date
2019-11-14, 1398/08/23
Registrant information
Name
Mahzad Yousefian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 0739
Email address
n.hagshenas@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ketofol with dexmedetomidine on anesthesia in patients undergoing dilatation and curettage
Public title
Comparison of the effect of ketofol with dexmedetomidine on anesthesia in patients undergoing dilatation and curettage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages over 16 years and less than 65 years
Candidate of dilatation and curettage with grade 1 and 2 ASA
Participation in the study
Exclusion criteria:
Under 16 years
There is an underlying disease like cancer
Age
From 16 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Ardabil University of Medical Sciences
Street address
No. 1, Daneshgah Ave
City
Ardabil
Province
Ardabil
Postal code
5613874758
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.ARUMS.REC.1398.266
Health conditions studied
1
Description of health condition studied
dilatation and curettage
ICD-10 code
O03.9
ICD-10 code description
Complete or unspecified spontaneous abortion without complication
Primary outcomes
1
Description
The main outcome in the study of apnea or hypoventilation during anesthesia is.
Timepoint
The patient will be monitored continuously during anesthesia.
Method of measurement
Given the pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The first group will be administered ketofol at a ratio of ketamine (0.5 mg / kg) to propofol (1 mg / kg) for 10 minutes, then 1 µg / kg / h and then 1% isoflurane.
Category
Treatment - Drugs
2
Description
Intervention group2: Intervention group: Dexmedetomidine will be administered to patients in the second group at a dose of 1 mg / kg / stat for 10 minutes, then 1 µg / kg / h and then 1% isoflurane.
Category
Treatment - Drugs
3
Description
Control group: Propofol 1 mg / kg and then isoflurane 1% will be given to patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Negin Haghshenas
Street address
No. 1 , Moallem Ave
City
Ardabil
Province
Ardabil
Postal code
5613843568
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Parvaneh Naftchi
Street address
No. 1, Faneshgah Ave
City
Ardabil
Province
Ardabil
Postal code
5613874785
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mahzad Yousefian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 1, Moallem Ave
City
Ardabil
Province
Ardabil
Postal code
5613847598
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mahzad Yousefian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 1, Moallem Ave
City
Ardabil
Province
Ardabil
Postal code
5613847574
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mahzad Yousefian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 1, Moallem Ave
City
Ardabil
Province
Ardabil
Postal code
5613874587
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The questionnaires will be made available anonymously and with a file number.
When the data will become available and for how long
After completing the study
To whom data/document is available
اساتید دانشگاه ها
Under which criteria data/document could be used
In order to find out how to work in SPSS file, anonymous questionnaires will only be available with file number.
From where data/document is obtainable
Contact Dr. Mahzad Yousefian.
What processes are involved for a request to access data/document
En Information is available after contacting Dr. Mahzad Yousefian and University approval