Effective and better control of patients pain during and after surgery
Design
Clinical trial with control group with parallel groups, one side blinding, with blinded outcome assessment, randomized, phase 3 on 50 patients.
Settings and conduct
Adult aged between 18 and 75 years old who have referred to Imam Reza and Ghaem hospital in Mashhad for gastrointestinal cancer surgeries were selected on the condition of non addiction and no history of drug allergy. After obtaining informed consent , they will be devided into two groups of control and intervention by blocked randomization method.At the end of the sampling, the data will be given to the data analyzer whom have been kept blind in assigning individuals to study groups for analysis.
Participants/Inclusion and exclusion criteria
Adults between 18 and 75 years
No addiction
Personal consent to participate in the project
No history of allergies to sufentanil and other drugs
Intervention groups
In the intervention group, immediately before induction of anesthesia, intrathecally received 0.2 micrograms per kilogram of weight of sufentanil(Caspian or Abureihan)and did not receive intravenous opioids during induction of anesthesia.
In the control group intravenously during induction of anaesthesia received 0.3 micrograms per kilogram of weight intravenous sufentanil and the need for drug repetition during and after surgery in these patients was assessed in a similar way.
Main outcome variables
pain relief and non-repeated use of intravenous opiud drugs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210129050174N1
Registration date:2021-12-20, 1400/09/29
Registration timing:registered_while_recruiting
Last update:2021-12-20, 1400/09/29
Update count:0
Registration date
2021-12-20, 1400/09/29
Registrant information
Name
Naser Naderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3601 9567
Email address
naderin971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Use high dose of intrathecal sufentanil for intraoperative and postoperative pain relife in gastrointestinal cancers surgeries
Public title
The effect of intrathecal sufentanil on analgesia of gastrointestinal cancer surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults who are between 18-75 years old
Informed consent for participation in project
Candidate for gastrointestinal cancers surgeries
Exclusion criteria:
No addiction
No history af allergy to sufentanil or other drugs
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
People who are going to enter the study,are devided into ten groups of five by blocked randomization method. The first group of five is assigned to the intervention or control group by heads or tails method.The next five person groups will be placed in the intervention or control group alternately according to the first group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer are kept blind to assignment to study groups and information is provided to them at the end of the project for analysis.
Placebo
Not 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
No 111,Jalal Al Ahmad 10, Jalal Al Ahmad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188875791
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.580
Health conditions studied
1
Description of health condition studied
Pain relife in gastrointestinal cancers surgeries
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain score in pain numerical scale
Timepoint
At the beginning of surgery and every twenty minutes until the end of surgery
Method of measurement
Pain numerical scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, immediately before induction of anesthesia, intrathecally received 0.2 micrograms per kilogram of weight of sufentanil (Caspian or Aburihan) and did not receive intravenous opioids during induction of anesthesia. During surgery with due attention to vital signs (20% increase in systolic blood pressure or heart rate compared to baseline values) and also after surgery by monitoring the patient in terms of expressing the first complaint of pain according to the pain scale Numerical and achieving score 3 In the pain table (according to the attached checklist) the need for re-administration of analgesic drug was assessed.
Category
Treatment - Drugs
2
Description
Control group: They receive 0.3 micrograms per kilogram of intravenous sufentanil weight.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Seyyed Alireza Bameshki
Street address
Imam reza hospita square, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3878
Email
IRH@mums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Graem hospital
Full name of responsible person
Alireza Bameshki
Street address
Ahmadabad Blvd, Shariati square
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۸۷۱۴۵۷۸۵
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Research and Technology,Ghoreshi building, building,Daneshgah Ave.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@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
Seyyed Alireza Bameshki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department Office, 610 building,Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
0098513858387
Email
bameshkiar@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyyed Alireza Bameshki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department Office,610 building,Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3878
Email
bameshkiar@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naser Naderi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 111, Jalal al ahmad 10 Ave, Jalal al ahmad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188875791
Phone
+98 51 3601 9567
Fax
Email
naderin971@mums.ac.ir
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
No - There is not a plan to make this available
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
No - There is not a plan to make this available
Title and more details about the data/document
The main outcome of the study is shared.
When the data will become available and for how long
Access starts from Mehr 1401
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use the data for further studies
From where data/document is obtainable
Dr. Seyyed Alireza Bamshki - Anesthesiology Department of Imam Rez Hospital
What processes are involved for a request to access data/document
Submit a request via email to Dr. Seyed Alireza Bamshki
bameshkiar@mums.ac.ir