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Preventive effect of intramuscular ketamine and methadone on pain after laparoscopic cholecystectomy

Protocol summary

Study aim
The Postoperative pain of laparoscopic cholecystectomy is one of the most common complications of this surgery. Analgesic drugs are commonly used to control this pain. Therefore, considering the importance of this issue, the current study aimed to examine the preventive effect of intramuscular ketamine and methadone on pain after laparoscopic cholecystectomy.
Design
90 patient candidates for laparoscopic cholecystitis surgery participated in this double-blind, randomized clinical trial study, with informed consent in Al-Zahra and Kashani hospitals in 2015-2017
Settings and conduct
Double-blind, randomized clinical trial study , 90 patents in Al-Zahra and Kashani hospitals in 2015-2017.
Participants/Inclusion and exclusion criteria
The entrance criterias included candidates for laparoscopic cholecystectomy, American Society of Anesthesiologists class 1 or class 2 (ASA), and the age between 18 and 75 years. Patients with a history of addiction to benzodiazepines or narcotics, including methadone, were not included in the study (exclusion criterion). If the duration of the surgery was longer (more than two hours), the surgical procedure was to be changed to laparotomy, a blood transfusion to the patient was required, or the type of anesthesia was to be changed, the patient would be excluded from the study
Intervention groups
The patient candidates were randomly divided into three groups. The first group received 1.5mg / kg ketamine, the second group received 0.15mg / kg methadone, and the third group received preoperative normal saline intra-muscularly
Main outcome variables
Hemodynamic changes, postoperative pain, the need for analgesic drugs, and the side effects of the procedure were investigated in the groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190127042511N1
Registration date: 2019-12-13, 1398/09/22
Registration timing: retrospective

Last update: 2019-12-13, 1398/09/22
Update count: 0
Registration date
2019-12-13, 1398/09/22
Registrant information
Name
Alireza Babaeizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 4561
Email address
alirezabbz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
2016-01-21, 1394/11/01
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
2018-01-21, 1396/11/01
Scientific title
Preventive effect of intramuscular ketamine and methadone on pain after laparoscopic cholecystectomy
Public title
Preventive effect of intramuscular ketamine and methadone on pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
candidates for laparoscopic cholecystectomy ASA(American Society of Anesthesiologists) 1 or 2
Exclusion criteria:
Patients with a history of addiction to benzodiazepines or narcotics, including methadone
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience sampling was done in these patients .the patients were randomly divided into three equal groups: ketamine, methadone, and control. Random Allocation Software was used to divide the patients into three groups randomly.It should be noted that the person who randomized the patients using the software was not aware of the conduction of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The prescriber, statistical analyzer, and data collector were not aware of the types of groups and were blinded by the researcher
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of isfahan University of Medical Sciences
Street address
Hezarjerib ave
City
isfahan
Province
Isfehan
Postal code
Approval date
2016-01-10, 1394/10/20
Ethics committee reference number
IR.med.rec.1397.876

Health conditions studied

1

Description of health condition studied
Pain control after cholecystectomy Surgery
ICD-10 code
K80
ICD-10 code description
Cholelithiasis

Primary outcomes

1

Description
Pain score
Timepoint
5 min
Method of measurement
Visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: One Intramuscular injection of 1.5mg per kg from 5 % Solution(50 mg in 1 ml) ketamin(Rotexmed co) before incision.injection site : deltoid muscle
Category
Prevention

2

Description
Intervention group 2:One intramuscular injection of 0.15 mg per kg methadone from 0/5% Solution (5 mg in 1 ml) before incision.injection site : deltoid muscle
Category
Prevention

3

Description
Control group: One injection of same volume intramuscular sterile water before incision.injection site : deltoid muscle
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital of isfahan
Full name of responsible person
Dr Gholamreza khalili
Street address
Shohada sofe
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Email
Alzahra@med.mui.ac.ir
Web page address
http://alzahra.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza khalili
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Fax
+98 31 3668 8597
Email
med@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza khalili
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Molasadra
City
Isfahan
Province
Isfehan
Postal code
8168634771
Phone
+98 31 3669 4561
Email
khalili@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza babaei zadeh
Position
Resident of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tayeb
City
Isfahan
Province
Isfehan
Postal code
8136651856
Phone
+98 31 3224 3652
Email
alirezabbz@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza babaei zadeh
Position
Resident of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tayeb
City
Isfahan
Province
Isfehan
Postal code
8136651856
Phone
003132243652
Email
alirezabbz@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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