Assess the level of pain control by Ketorolac vs Dexmedetomidine after left lobectomy lung surgery
Design
This study is a randomized controlled trial, with 2 parallel groups. Patients are blinded about allocation to each of 2 intervention groups and are assigned to the mentioned groups using random number table.
Settings and conduct
In Ghaem hospital, patients of both sex, who need Left lobectomy surgery under general anesthesia, will be randomly divided into 2 groups, receiving Ketorolac or Dexmedetomidine. They will be blinded about allocation to each group.
Participants/Inclusion and exclusion criteria
Inclusion: age more than 18 years, Informed consent form must be signed, They were scheduled for Left lobectomy surgery under general anesthesia.
Exclusion: History of allergy to our study drugs, History of renal or hepatic failure, History of PUD.
Intervention groups
Intervention group 1: Patients will receive Ketorolac, 30 mg every 6 hours as infusion.
Intervention group 2: Patients will receive infusion of Dexmedetomidine, 1 microgram/kg/10 minutes as loading dose and 0.2 microgram/kg/h as maintenance.
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180521039753N1
Registration date:2018-05-27, 1397/03/06
Registration timing:registered_while_recruiting
Last update:2018-05-27, 1397/03/06
Update count:0
Registration date
2018-05-27, 1397/03/06
Registrant information
Name
Seyed Iman Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 0000
Email address
hashemipi941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of dexmedetomidine and ketorolac to reduce post-surgery pain of patients with left lobectomy
Public title
Comparing the effect of dexmedetomidine and ketorolac to reduce post-surgery pain of lobectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age more than 18 years
Informed consent form must be signed
They were scheduled for Left lobectomy surgery under general anesthesia.
Exclusion criteria:
َHistory of allergy to our study drugs
History of renal or hepatic failure
History of PUD
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Using random number table, patients will be divided into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are blinded about allocation to intervention group 1 (receiving Ketorolac after surgery) and intervention group 2 (receiving Dexmedetomidine after surgery).
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
Qoreishi Building, Daneshgah Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
IR.MUMS.fm.REC.1396.583
Health conditions studied
1
Description of health condition studied
Post-surgery pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain intensity
Timepoint
Immediately after surgery and 2, 4, 6, 8, 12, 16, 20 and 24 hours after surgery
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive Ketorolac, 30 mg every 6 hours as infusion.
Category
Treatment - Drugs
2
Description
Intervention group: Patients will receive infusion of Dexmedetomidine, 1 microgram/kg/10 minutes as loading dose and 0.2 microgram/kg/h as maintenance.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Seyed Iman Hashemi
Street address
Ahmad abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3801 2469
Email
hashemipi941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Qoreighi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 1538
Email
vcresearch@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
Seyed Iman Hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghaem hospital, Ahmad abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3801 2469
Email
hashemipi941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Sharifian Attar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahmad abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3801 2469
Email
SharifianA@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Iman Hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghaem hospital, Ahmad abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3801 2469
Email
hashemipi941@mums.ac.ir
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
To protect the privacy of the participants in the study
Study Protocol
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available