Comparison of Dexmedetomidine- Ketamin and Fentanyl-Ketamin in sedation and analgesia in cystoscopy
Design
This double-blind and clinical trial .60 patients who are candidates for cystoscopy at Valiasr Hospital in Arak.
Settings and conduct
This double-blind and clinical trial will be conducted on 60 patients who are candidates for cystoscopy at Vali Asr Hospital in Arak. The patients are divided into two groups by simple randomization with random number table.This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind). Assessor and analyzer and participant are not aware of group allocation
Participants/Inclusion and exclusion criteria
Inclusion criteria:Both gender, age 18 to 65 years old, ASA Class 1 and 2, cystoscopy candidate, no allergy to used drugs,no history of cardio-pulmonary-liver and kidney disease,lack of Obstructive Sleep Apnea (OSA), no history of drug addiction or other psychotropic substances, no history of use of drug or alcohol ,no history of psychological illness
Exclusion criteria:lack of consent
Intervention groups
Dexmedetomidine and ketamine: We inject 0.5 milligram in kilogram Ketamin and 1 milligram in kilogram of Dexmedetomidine.
The Fentanyl and Ketamine: We inject 0.5 milligram in kilogram Ketamin and fentanyl 2 micro gram in kilogram.
Main outcome variables
Duration of cystoscopy-pain-satisfaction-scrob-rumsy-mean arterial blood pressure-heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N105
Registration date:2019-04-21, 1398/02/01
Registration timing:registered_while_recruiting
Last update:2019-04-21, 1398/02/01
Update count:0
Registration date
2019-04-21, 1398/02/01
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-02, 1397/04/11
Expected recruitment end date
2019-07-02, 1398/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dexmedetomidine- Ketamin and Fentanyl-Ketamin in sedation and analgesia in cystoscopy
Public title
Comparison of Dexmedetomidine- Ketamin and Fentanyl-Ketamin in analgesia in cystoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both sexes
Age 18 to 65 years old
ASA Class 1 and 2
Cystoscopy candidate
No allergy to used drugs
No history of cardio-pulmonary-liver and kidney disease
Lack of Obstructive Sleep Apnea (OSA)
No history of drug addiction or other psychotropic substances
No history of acute drug or alcohol poisoning
No history of psychological illness
Exclusion criteria:
Dissatisfaction to participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.ARAKMU.REC.1397.108
Health conditions studied
1
Description of health condition studied
cystoscopy
ICD-10 code
ICD-10 code description
cystoscopy
Primary outcomes
1
Description
Duration of cystoscopy
Timepoint
After intervention
Method of measurement
hours
2
Description
pain
Timepoint
Every 5 minutes to 60 minutes
Method of measurement
Visual analog scale
3
Description
relaxation
Timepoint
Initially and after analgesia, and every 5 minutes during the procedure until 60 minutes later
Method of measurement
Ramsy score
4
Description
satisfaction
Timepoint
After intervention
Method of measurement
questionnaire
5
Description
mean arterial blood pressure
Timepoint
Every 5 minutes after the start of anesthesia until the end of the cystoscopy and during recovery
Method of measurement
mmHg
6
Description
heart rate
Timepoint
Every 5 minutes after the start of anesthesia until the end of the cystoscopy and during recovery
Method of measurement
count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dexmedetomidine and ketamine: We inject 0.5 milligram in kilogram Ketamin and 1 milligram in kilogram of Dexmedetomidine.
Category
Treatment - Drugs
2
Description
Intervention group: The Fentanyl and Ketamine: We inject 0.5 milligram in kilogram Ketamin and fentanyl 2 micro gram in kilogram.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Hesamedin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?