Comparative study of the effect of two-dose infusion of 0.3 and 0.6 μg / kg dexmedetomidine during surgery on changes in hemodynamic parameters and pain in patients undergoing spinal surgery under general anesthesia
The aim of this study was to compare the effect of infusion of 0.3 and 0.6 μg / kg dexmedetomidine during surgery on changes in hemodynamic parameters and pain in patients undergoing spinal surgery under general anesthesia.
Design
In this triple blind randomized controlled clinical trial of phase 3, 81 patients who are candidates for spinal surgery are distributed in three groups of 27 patients. In the first and second groups, 0.3 and 0.6 micrograms per kilogram of dexmedetomidine, respectively, and in the third group with a similar volume of normal saline as an intravenous infusion at the time of induction of anesthesia. Hemodynamic parameters during surgery and recovery and severity of postoperative pain are evaluated and compared in three groups.
Settings and conduct
This randomized three-blind clinical trial study was performed in 2021in Al-Zahra Hospital in Isfahan on patients who were candidates for spine surgery.
Participants/Inclusion and exclusion criteria
In this study, patients who are candidates for spinal surgery under general anesthesia, who are in the age range of 18 to 65 years and have no history of heart and liver and kidney disease and agree to participate in the study are included in the study.
Intervention groups
In this study, three groups enter the research. The first group: patients injected with 0.3 micrograms per kilogram of dexmedetomidine, the second group: under injected with 0.6 micrograms per kilogram of dexmedetomidine. Group 3: Under normal saline injection of the same volume as an intravenous infusion at the time of induction of anesthesia.
Comparative study of the effect of two-dose infusion of 0.3 and 0.6 μg / kg dexmedetomidine during surgery on changes in hemodynamic parameters and pain in patients undergoing spinal surgery under general anesthesia
Public title
Comparison of injection of two different amounts of dexmedetomidine on blood pressure, heart rate and postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for spinal laminectomy under general anesthesia
ASA(American Society of Anesthesiologists) 1 & 2
Patient consent to participate in the study
Exclusion criteria:
History of kidney and liver disease
History of allergy to any anesthetic drug
Heart failure or a history of miocardial infarction
Drug and alcohol addiction or mental illness
Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are distributed in three groups by simple random allocation method. To do this, the letter A is written on 27 cards, the letter B is written on 27 cards and the letter C is written on 27 cards, and all the cards are put in a box and shuffled well. At the time of each patient's visit, he / she is asked to take a card out of the box. According to the letter written on the card, the patient is assigned to the group of dexmedetomidine 0.3, dexmedetomidine 0.6 or control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is done in three blinds. Patient researchers and analysts are unaware of patients being assigned to groups. The drugs are prepared by an operating room staff who is not in the study, in similar and coded syringes, and are given to the researcher for injection. After analyzing the data, the codes are opened and the results are compiled accordingly.
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
Research deputy, Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
IR.MUI.MED.REC.1399.195
Health conditions studied
1
Description of health condition studied
Disk herniation
ICD-10 code
M51:26
ICD-10 code description
Disk herniation
Primary outcomes
1
Description
Blood pressure
Timepoint
Every half hour during surgery and recovery
Method of measurement
Pulse Oximeter
2
Description
Hear rate
Timepoint
Every half hour during surgery and recovery
Method of measurement
Pulse Oximeter
3
Description
Percentage of blood oxygen saturation
Timepoint
Every half hour during surgery and recovery
Method of measurement
Pulse Oximeter
4
Description
Post operative pain
Timepoint
Every 30 minutes from the enterance to recovery and 2, 8, 24 and 48 hours after surgery
Method of measurement
Using a visual analog scale(VAS) that divides patients' pain intensity from zero to 10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Patients receiving intravenous infusion of 0.3 μg / kg dexmedetomidine at the time of induction of anesthesia
Category
Treatment - Drugs
2
Description
Intervention group2: Patients receiving intravenous infusion of 0.6 μg / kg dexmedetomidine at the time of induction of anesthesia
Category
Treatment - Drugs
3
Description
Control group: Patients undergoing normal saline intravenous infusion with similar volume of intervention drugs at the time of induction of anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mahshad Rahimian
Street address
Alzahra hospital. Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
k.mahshad-net@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research deputy, Isfahan Univarsity of Medical Sciences, Hezarjerib street,
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3060
Email
sh_haghjoo@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
Mahshad Rahimian
Position
Resident of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra hospital, Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
k.mahshad-net@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra hospital, Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
m_masoudifar@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Alzahra hospital, Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
al.mehrabi@gmail.com
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
The plan belongs to a government agency and cannot be shared.