Comparison of Anesthesia's Effect with Gabapentin and Parastamol as a precursor on hemodynamic values during anesthesia with Remy Fentanyl in adult heart surgery
Investigating and comparing the effect of gabapentin and paracetamol on hemodynamic values during heart surgery in adults
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 30 patients in each group, which rand function of Excel software was used for randomization.
Settings and conduct
This study was conducted in Chamran Hospital, Isfahan, on patients undergoing heart surgery, and the study was conducted in a double-blind manner.
Participants/Inclusion and exclusion criteria
Patients who undergo heart surgery
Intervention groups
paracetamol group, who are given one gram of intravenous paracetamol one hour before the operation
Gabapentin group, which is given 100 mg of paracetamol one hour before the operation
Main outcome variables
Hemodynamic stability including heart rate and blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221210056764N1
Registration date:2023-06-13, 1402/03/23
Registration timing:registered_while_recruiting
Last update:2023-06-13, 1402/03/23
Update count:0
Registration date
2023-06-13, 1402/03/23
Registrant information
Name
Amene Roodhelle
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 5555
Email address
dr.amene1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Anesthesia's Effect with Gabapentin and Parastamol as a precursor on hemodynamic values during anesthesia with Remy Fentanyl in adult heart surgery
Public title
The effect of preemptive in cardiac surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Adults undergoing heart surgery
No emergency heart surgery
Exclusion criteria:
Uncontrolled underlying disease
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization technique was employed in this study with the statistical analysis being conducted using SPSS version 20 software . Upon assigning a unique code to each patient , the randomization software was utilized to allocate patients into either the controlor test grouos . Patients assigned to the test groupe were administered premedication prior to the operation and Remifentanyl during the procedure to manage any pain . The controlgroupe , on the other hand , recived placebo before the operation and Morphine and Fentanyl during the operation to alleviate pain .
Blinding (investigator's opinion)
Triple blinded
Blinding description
After informing the patient that it is necessary to receive pre-medication before surgery to have fewer complications, one of the drugs studied will be given to him
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
Shohadaie Soffe Ave., Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2022-11-27, 1401/09/06
Ethics committee reference number
IR.MUI.MED.REC.1401.313
Health conditions studied
1
Description of health condition studied
Ischemic cardiac disease
ICD-10 code
T82.8
ICD-10 code description
Other specified complications of cardiac and vascular prosthetic devices, implants and grafts
Primary outcomes
1
Description
In-operative hemodynamic values
Timepoint
Measurement of hemodynamic levels before anesthesia and every 15 minutes until the end of anesthesia
Method of measurement
Mercury pressure gauge
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will be given 100mg Gabapentine (capp Gabepentine 100mg - Sanamed )the night before surgury and 1 gram of intravenous Paracetamol one hour before the start of surgery and during operation , patients recieve Remofentanyl if necessary.
Category
Placebo
2
Description
Control group: In this groupe patients recieve placebo and during operation patients recive Morphin and Fentanyl if necessary .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Dr. Mojtaba Mansuri
Street address
Dr. Chamran Shahid Heart Hospital . salman Ave
City
Isfahan
Province
Isfehan
Postal code
8158388994
Phone
+98 31 3261 1404
Email
dr.amene1990@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
dr Mojhgan Mortazavi
Street address
Soffe blvd . Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
dr.amene1990@gmail.com
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
Amene Roodhelle
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Sofe blvd. shahid keshvari. Esfahan. Iran
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
Email
dr.amene1990@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amene Roodhelle
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Soffe blvd. Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
dr.amene1990@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amene Roodhelle
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shohadaie Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
dr.amene1990@gmail.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
Undecided - It is not yet known if there will be 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