Comparison of the sedative effect of Remifentanil and Dexmidetomidine in patients undergoing venous arterial fistula implantation
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 will be performed on 32 patients. Excel software rand function will be used for randomization.
Settings and conduct
In the operating room, the severity of pain in patients will be determined before surgery and based on the Visual Analogue Scale (VAS) system.
Both patients and anesthesiologists will be completely unaware of the nature of prescription vials. So the vials will be covered with foil. Then, the intensity of postoperative pain will be measured based on the VAS at the moment after surgery in the operating room and also every half hour, up to two hours after surgery in the recovery and surgery ward.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age group 19 to 60 years - Patients with stable hemodynamic status
Exclusion criteria: 1) Patients with a history of cardiovascular abnormalities, 2) Patients with a history of chronic diseases such as liver disorders, 3) Patients with a history of allergies to anesthetics, including opioids, 4) Patients with a history of use Opium, 5) Pregnant or lactating women, 6) Recent respiratory tract infection, 7) Severe bronchopulmonary disease
Intervention groups
One group will be received Dexamidomethidine (bolus dose of 0.4 μg / kg intravenously over 10 minutes and maintenance dose of 0.5 to 1.00 μg / kg / min) and the other group will be received Remifentanil (bolus dose of 0.5 μg / kg). Intravenously over 10 minutes and a maintenance dose of 0.5 to 0.25 micrograms per kilogram per minute.
Main outcome variables
Pain score
Requires opioid administration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047269N1
Registration date:2020-11-26, 1399/09/06
Registration timing:registered_while_recruiting
Last update:2020-11-26, 1399/09/06
Update count:0
Registration date
2020-11-26, 1399/09/06
Registrant information
Name
Alireza Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1112
Email address
dr.alireza_maleki@irimed.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the sedative effect of Remifentanil and Dexmidetomidine in patients undergoing venous arterial fistula implantation
Public title
Comparison of the sedative effect of Remifentanil and Dexmidetomidine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 19 to 60 years
Patients with stable hemodynamic status
Exclusion criteria:
Patients with a history of cardiovascular abnormalities
Patients with a history of chronic diseases such as liver disease
Patients with a history of allergies to anesthetics, including opioids
Patients with a history of opium use
Pregnant or lactating women
Recent respiratory tract infection
Severe bronchopulmonary disease
Age
From 19 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups by permuted block randomization. The size of the blocks will randomly include 4 and 6 blocks, in each block, two and three participants will be equally placed in each of the intervention and control groups, respectively. One group receiving dexamidomethidine (bolus dose of 0.5 μg / kg intravenously over 10 minutes and maintenance dose of 0.5 to 1.00 μg / kg / min) or remifentanil (bolus dose of 0.5 μg / kg) Intravenously for 10 minutes at a maintenance dose of 0.5 to 0.25 μg / kg / min.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both patients and anesthesiologists will be completely unaware of the nature of prescription vials. For this purpose, vials will be covered with foil. Patients will be informed that they are participating in a research study but are not aware of the type of group assigned.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
At the moment after the operation and also every half an hour, up to two hours after the operation
Method of measurement
Use of Visual Analogue Scale (VAS) scoring system
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
After surgery
Method of measurement
Observation
2
Description
Hypertension
Timepoint
After surgery
Method of measurement
Mercury barometer
3
Description
Oxygen saturation
Timepoint
After surgery
Method of measurement
Pulse oximetry
4
Description
Tachycardia and bradycardia
Timepoint
After surgery
Method of measurement
Monitoring
Intervention groups
1
Description
Intervention group 1: Dexamidomethidine administration (bolus dose of 0.4 μg / kg intravenously over 10 minutes and maintenance dose of 0.5 to 1.00 μg / kg / min). Its manufacturer is Exir Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Intervention group 2: Remifentanil administration (bolus dose of 0.5 μg / kg intravenously over 10 minutes and maintenance dose of 0.5 to 0.25 μg / kg / min). Its manufacturer is Exir Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hasheminejad Hospital
Full name of responsible person
Alireza Maleki
Street address
Hasheminejad Hospital, Valinejad street, Valiasr Street
City
Tehran
Province
Tehran
Postal code
۱۹۶۹۷۱۴۷۱۳
Phone
+98 21 81161
Email
support@hkc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.seyed-Abbas Motevallian
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?