Determining the effect of ketamine and oxytocin in comparison with pethidine on postoperative pain control in patients candidates for cholecystectomy referred to Shohada-e-Ashayer and Rahimi hospitals
Design
Patients were divided into 3 groups (٢ intervention group and one control group) by random number table.
The first group was prescribed0.5 units per kilogram of patient weight oxytocin and ketamine 0.5 mg per kilogram of patient weight after extubation.
The second group received 0.5 mg of pethidine per kg body weight
And the third group, the control group, without intervention
Ondansetron 4 mg and sufentanil 5 μg were administered equally to all patients after extubation.
The patient's pain was assessed based on VAS 30 minutes after recovery, 1 and 2 hours after surgery
Settings and conduct
This study was performed on patients referred to Shohada-e-Ashayer and Shahid Rahimi Hospitals of Lorestan University of Medical Sciences.Blindfolding is performed on all patients, collecting and analyzing data
Participants/Inclusion and exclusion criteria
Inclusion criteria are patients in the age range of 30-60 years who have no underlying (ASA class1) and pulmonary problems and no history of chronic pain after surgery. Exclusion criteria are all patients with a history of chronic pain and patients with specific drug dependence such as opium and patients with a history of psychiatric illness
Intervention groups
The first group received ketamine and oxytocin
The second group received pethidine
The third group is the control group
The effect of ketamine and oxytocin on postoperative pain control in patients undergoing elective laparoscopic gallbladder surgery
Public title
The effect of ketamine and oxytocin on pain control, nausea, blood pressure, heart rate, satisfaction, postoperative blood oxygen saturation in patients undergoing elective laparoscopic gallbladder surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 30-60 years who have undergone laparoscopic cholecystectomy
No pulmonary disease
ASA class 1(American Society of Anesthesiologists ) is a system for assessing the fitness of patients before surgery
No history of chronic pain after surgery
Exclusion criteria:
History of chronic pain
Specific drug dependence such as opium
History of psychiatric illness
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table
Random number table
Table of Random Numbers A set of masses of
Numbers that are produced without a specific pattern or order and in a completely random manner and are in the form of a table. In order to use a random number table, the researcher must first preset the table to read the numbers (for example, up, down, left, or right (the researcher's second assumption is to consider numbers for different groups), for example, even numbers for intervention. A and odd numbers for
Intervention B, another method of taking the number 0-40 for intervention A and the number 41-80 for
Intervention B is the numbers 120-181 for group C, then the researcher touches one of the numbers and moves in one of the predetermined directions and records the numbers and
Allocates different groups
Blinding (investigator's opinion)
Triple blinded
Blinding description
All blind people only know that participants are divided into 4 groups, but do not know the type of treatment intervention in each group to control pain, nausea, hemodynamic changes such as blood pressure and heart rate, arterial oxygenation and patient satisfaction, and assign patients in 4 groups. It was done completely randomly through a table of random numbers, which is described as how to do it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Moallem St., Shahid Anoushirvan Rezaei Sq., University of Medical Sciences
City
Khoram-Abad
Province
Lorestan
Postal code
6813833946
Approval date
2019-12-01, 1398/09/10
Ethics committee reference number
IR.LUMS.REC.1398.226
Health conditions studied
1
Description of health condition studied
Status and comparison of pain after laparoscopic cholecystectomy in 3 study group
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Status and comparison of nausea after laparoscopic cholecystectomy in 3 study group
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Status and comparison of hemodynamic changes (blood pressure, heart rate, blood oxygenation) after laparoscopic cholecystectomy in 3 study group
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score based on visual analague scale
Timepoint
After surgery in the recovery room, 1 and 2 hours after surgery
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving 0.5 mg of ketamine per kg of patient weight and oxytocin 0.5 units per kg of patient weight immediately after patient extubation. All of the following were similar in all three groups: Time Operation ١ - ٢ Hour, drugs used during surgery (for premedication of fentanyl 1-2 micrograms per kilogram - Midaz slide 0/05-0/15mg per kg body weight - Atracorium 0/5mg per kg Kg patient weight, propofol 1.5-2/5 mg / kg body weight, under isoflurane1/2% inhalation anesthesia as maintenance anesthetic, similar serum therapy
Category
Rehabilitation
2
Description
Intervention group: Receiving 0.5 mg of pethidine per kg of patient weight is prescribed immediately after the patient's extubation. All of the following were the same in all three groups: time of operation 1-2 hour, intraoperative drugs (for premedication from Fentanyl 1-2 micrograms per kilogram - Midazolam 0/05-0/15 milligrams per kilogram body weight - Atracorium 0.5 mg per kilogram patient weight, Propofol 1.5-2.5 mg Per kilogram of body weight, under inhaled anesthesia with iso-fluorine 1/2 ٪ as maintenance anesthetic, similar serum therapy
Category
Rehabilitation
3
Description
Control group: Do not receive medication, however, each group was prescribed 4 mg of ondansetron and 5 micrograms of sufentanil after extubation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye- Ashayer Hospital
Full name of responsible person
Maryam Baghizadeh Baghdashti
Street address
Enqelab Ave,Shohadaye- Ashayer Hospital
City
Khoram-Abad
Province
Lorestan
Postal code
6816933132
Phone
+98 66 3323 6401
Email
M.baghizadeh65@gmail.com
2
Recruitment center
Name of recruitment center
Shahid-Rahimi Hospital
Full name of responsible person
Maryam Baghizadeh Baghdashti
Street address
Azadi Square, not far from Safavid Bridge, Shahid Rahimi Medical Center
City
Khoram-Abad
Province
Lorestan
Postal code
6813816314
Phone
+98 66 3333 6141
Fax
+98 66 3333 6151
Email
M.baghizadeh65@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Arash Karimi
Street address
Moallem St., Shahid Anoushirvan Rezaei Sq., University of Medical Sciences
City
Khoram-Abad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
M.baghizadeh65@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arash karimi-maryam baghizadeh
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Maryam Baghizadeh Baghdashti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Enqelab Ave,Shohadaye-Ashayer Hospital
City
Khoram-Abad
Province
Lorestan
Postal code
6816933132
Phone
+98 66 3323 6401
Fax
+98 66 3323 6404
Email
M.baghizadeh65@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Arash Karimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Enqelab Ave,Shohadaye -Ashayer Hospital
City
Khoram-Abad
Province
Lorestan
Postal code
6816933132
Phone
+98 66 3323 6401
Fax
+98 66 3323 6401
Email
M.baghizadeh65@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Maryam Baghizadeh Baghdashti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Enqelab Ave,Shohadaye-Ashayer Hospital
City
Khoram-Abad
Province
Lorestan
Postal code
6816933132
Phone
+98 66 3322 6401
Fax
+98 66 3323 6401
Email
M.baghizadeh65@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Privacy of the patients
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Results can be shared after Unidentifiablation people
When the data will become available and for how long
Access period starts, 6 months after the results are published
To whom data/document is available
کلیه افراد
Under which criteria data/document could be used
For the use of other researchers with the permission of the supervisor and the approval of the research assistant
From where data/document is obtainable
M.baghizadeh65@gmail.com
What processes are involved for a request to access data/document
After obtaining the above items, the requested items will be sent