Determining the Effect of Ketamine on pain after open renal stone surgery
Design
Double-blind clinical trial study, simple randomization, 28 patients in each group, phase 1 clinical trial.
Settings and conduct
After obtaining the approval of the Ethics Committee of the Faculty of Medicine and obtaining informed consent from the patients in Imam Reza Hospital and Ghaem Hospital, patients who are candidates for open renal surgery are entered. Patients with age between 18 and 65 years and ASA 1, 2 classes are enrolled in the study and randomly assigned to the control and intervention groups using random software and then using closed envelopes. All patients receive premedication according to the standard protocol of the hospital and pre-mild sedation.
Participants/Inclusion and exclusion criteria
Patients Candidated to Open Kidney surgery are enrolled in the study, and patients with other diseases are excluded.
Intervention groups
Intervention group: ketamine injection (0.5mg / kg) (volume 2 cc) before skin incision
Control group (placebo, placebo): normal saline 2 cc before skin incision
Main outcome variables
Duration of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170429033680N10
Registration date:2018-12-03, 1397/09/12
Registration timing:registered_while_recruiting
Last update:2018-12-03, 1397/09/12
Update count:0
Registration date
2018-12-03, 1397/09/12
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of injection of ketamine before surgery to reduce pain after renal surgery
Public title
The effect of injection of ketamine before surgery to reduce pain after renal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-65 years old
ASA Class 1, 2
BMI less than 30
Candidate for open kidney surgery
Satisfaction to participate in the study
Exclusion criteria:
Sensitivity to the drug being studied
Drug and alcohol addiction
History of seizure and psychological illness
Use of any analgesic drug before surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize, we use a simple random method (random numbers table)
Blinding (investigator's opinion)
Double blinded
Blinding description
Using different enclosed envelopes. patients and researcher were unaware from type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical Sciences; International Offic Administration Center(Qoreishi Building) ; Daneshgah St., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2018-09-06, 1397/06/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.280
Health conditions studied
1
Description of health condition studied
kidney diseases
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Taking opioid drugs
Timepoint
Twenty-four hours after surgery
Method of measurement
NVR scale
Secondary outcomes
1
Description
Pain
Timepoint
24 hours after surgery
Method of measurement
vas Scale
Intervention groups
1
Description
Intervention group: Inject ketamine (0.5mg / kg) (2 cc volume) before skin incision
Category
Treatment - Drugs
2
Description
Control group: Prescribe cc 2 normal saline before skin incision
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Mohammd Alipour
Street address
Department of Anesthesiology, Imam Reza Hospital, Square Taghiabad, Khorasan Razavi, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3801 2612
Email
alipourm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences; International Offic Administration Center (Qoreishi Building) ; Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3843 3363
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Alipour
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Taghiabad Square