Comparison of total intravenous anesthesia(TIVA) with propofol and inhalation anesthesia with isoflurane in patients undergoing posterior lumbar fusion surgery: a randomized clinical trial
Comparison of total intravenous anesthesia with propofol and inhalation anesthesia with isoflurane in patients undergoing posterior lumbar fusion surgery
Design
This clinical trial will be conducted on 66 patients who are candidates for posterior lumbar fusion surgery. The studied samples will be selected as available and randomly divided into intervention groups. The samples are divided into two equal groups of isoflurane anesthesia (33 samples) and propofol anesthesia (33 samples) using the random block allocation method.
Settings and conduct
The present study is a randomized and blinded clinical trial study. The participants are randomly divided into two equal groups and the intervention will be done on them and its consequences will be evaluated in the two groups. In the implementation of this study, weighing the surgical gases and checking the bottle suction for the amount of bleeding, the BOEZART scale for the quality of the surgical field, the vas criterion for postoperative pain, RINVR index to evaluate postoperative nausea and vomiting, MMSE scale for cognitive status, QoR-40 questionnaire for quality of recovery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate patients for posterior lumbar fusion surgery with pedicle screw fixation(only 3 to 5 levels); 18-65 years; ASA I-II ; BMI less than 35 kg/m2
Exit criteria: allergic to anesthetics; severe chronic diseases; uncontrolled blood pressure; previous spine surgery; bleeding and coagulation disorders; history of frequent nausea and vomiting; mental disorders
Intervention groups
1. Inhalation anesthesia with isoflurane
2. Total intravenous anesthesia with propofol
Comparison of total intravenous anesthesia(TIVA) with propofol and inhalation anesthesia with isoflurane in patients undergoing posterior lumbar fusion surgery: a randomized clinical trial
Public title
Comparison of total intravenous anesthesia(TIVA) with propofol and inhalation anesthesia with isoflurane in patients undergoing posterior lumbar fusion surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for posterior fusion surgery of lumbar vertebrae with pedicle screw fixation method
Patients who will have only 3 to 5 levels of lumbar spine fusion
Willingness and consent to participate in the study
Age between 18 and 65 years
American Society of Anesthesiologists (ASA) Class I-II physical status
Body mass index (BMI) less than 35 kg/m2
Exclusion criteria:
Trauma patients
Allergy to anesthetics used in the study
Patients with severe chronic diseases (cardiovascular, respiratory, nervous, liver, kidney, electrolyte disorders)
patient with uncontrolled blood pressure
History of drug use
Patients who receive medication or liquid therapy outside of routine before, during and after surgery
History of bleeding disorders and treatment with anticoagulants
Excessive bleeding (more than MABL)
Women if they are menstruating
Abnormal coagulation profile (platelet count less than 50x103/µL, PTT greater than 50 seconds, or INR greater than 1.3 on preoperative testing)
Patients with a history of frequent nausea and vomiting and taking antiemetics in the 24 hours before surgery
Patients with mental disorders and mental retardation, dementia or schizophrenia
Recent brain surgery or cerebrovascular accidents
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The studied samples are selected randomly. Then, the patients will be randomly assigned to two groups using the 4-way random block method. Anesthesia will be performed in the first group using the intravenous method with propofol (Pof) and in the second group using the inhalation method with isoflurane (Iso). In this method, each of the generated random sequences is recorded on a card and the cards will be placed in sealed opaque envelopes in order. In order to maintain a random sequence on the outer surface of the envelopes, numbering will be done in the same order. Finally, the lid of the letter envelopes will be glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. For this purpose, four paper cards are prepared. The letter Pof (propofol) is written on two cards and the letter Iso (isoflurane) is written on the other two cards. The cards are mixed together and removed by the researcher consecutively without placing them. This operation is repeated for the number of eligible patients and the Pof and Iso group of each patient is determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the main researcher who is in charge of data collection and outcome evaluation, as well as the surgeon, will not be blinded.
The participants in this study and the person analyzing the data will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for research and technology, In front of the Mardom park, Shahid Fahmideh steet, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2024-08-10, 1403/05/20
Ethics committee reference number
IR.UMSHA.REC.1403.294
Health conditions studied
1
Description of health condition studied
Lumbar spinal stenosis
ICD-10 code
M48.07
ICD-10 code description
Spinal stenosis, lumbosacral region
2
Description of health condition studied
complications of total intravenous anaesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
3
Description of health condition studied
complications of inhalation anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
The amount of bleeding during the operation
Timepoint
30, 60, 90 and 120 minutes after the start of surgery
Method of measurement
Weighing the consumed gases and checking the amount of blood inside the suction bottle by subtracting the serum and other liquids used
2
Description
The quality of the surgical field
Timepoint
30, 60, 90 and 120 minutes after the start of surgery
Method of measurement
BOEZAART grading system will be used to check the quality of the surgical field
3
Description
postoperative pain
Timepoint
First, immediately after the stabilization of their conditions after the operation, and then 6 and 24 hours after the first measurement
Method of measurement
It will be measured using the VAS scale in two states of rest and cough
4
Description
The amount of opioid analgesic received after surgery
Timepoint
At the time of discharge from the hospital
Method of measurement
Injection syringe (in milliliters)
5
Description
Hemodynamic changes of the patient during surgery
Timepoint
Three minutes before the injection of drugs and the start of anesthesia induction, three minutes after induction and before intubation, three minutes after intubation, before changing the patient's position (from supine to prone), after changing the patient's position, Before making a surgical incision, from the time of making a surgical incision until the end of the drugs: every 10 minutes until the end of anesthesia, after the end of anesthesia, after applying reverse drugs, before removing the tracheal tube, after removing the tracheal tube
Method of measurement
The patient's hemodynamics will be evaluated using standard monitoring including mean arterial pressure (MAP), heart rate (HR), electrocardiogram (ECG), pulse oximetry (SpO2), non-invasive blood pressure (NIBP), capnography (ETCO2).
6
Description
Cognitive status
Timepoint
First before the operation and then 2 and 24 hours after the operation
Method of measurement
MMSE test will be used to evaluate cognitive dysfunction
7
Description
Extubation time
Timepoint
Immediately after surgery
Method of measurement
From the time of stopping the anesthesia for the patient until the moment of removing the endotracheal tube from the patient's larynx is considered as the patient's extubation time and is recorded with a digital clock.
8
Description
recovery time
Timepoint
After the completion of the surgery and anesthesia process
Method of measurement
After the completion of the surgery and anesthesia process and when the patient enters the recovery room, the exact moment of the patient's entry into this room as well as the moment of the patient's exit from the recovery room and transfer to the ward are measured and considered as the recovery time. . Our criterion in this study to determine that a patient is eligible to be discharged from the recovery department is an Aldert score of 9 or 10.
9
Description
Quality of recovery after surgery
Timepoint
24 hours after surgery
Method of measurement
The quality of recovery after surgery will be evaluated by the QOR-40 quality of recovery questionnaire.
10
Description
Total operation time
Timepoint
From the start to the end of surgery
Method of measurement
The total operation time will be measured by a digital clock from the moment of creating a skin incision to the moment of placing the dressing on the sutured wound site.
11
Description
Postoperative nausea and vomiting
Timepoint
First before the operation and then 12 and 24 hours after the operation
Method of measurement
The patient's nausea and vomiting after surgery will be evaluated with the Rhodes Nausea and Vomiting Index (RINVR) questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Total intravenous anesthesia group with propofol, for these patients, a combination of propofol (100-200 µg/kg/min) and remifentanil will be used. In fact, a 50cc syringe containing propofol and remifentanil is placed in the infusion pump device and will be set to the desired time and will be renewed when the contents of the syringe are finished. The dose of muscle relaxant (atracurium) will be repeated during the operation if the patient and the surgical team need it and the anesthesia team sees fit.
Category
Treatment - Surgery
2
Description
Control group: Inhalation anesthesia group with isoflurane, a combination of isoflurane gas (mac: 1-2), nitrous oxide gas (0.05 L/kg/min) and oxygen gas (0.05 L/kg/min) will be used for these patients. The dose of narcotic drugs (fentanyl) and muscle relaxant (atracurium) will be repeated during the operation if the patient and the surgical team need it and the anesthesia team sees fit. Propofol drip will not be used during surgery in this group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Behzad Imani
Street address
Shahid Beheshti Blvd, Hamedan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۵۷۳۷۴۶۱
Phone
+98 81 3264 0030
Email
Besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Behzad Imani
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St., Pazhouhesh Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
alireza.abdi.st@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Abdi
Position
MSc student in Surgical technology
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No 110, Imam Khomeini St., Maryanaj
City
Hamadan
Province
Hamadan
Postal code
6514144868
Phone
+98 81 3426 3597
Email
alireza.abdi.st@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Abdi
Position
MSc student in Surgical technology
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No 110, Imam Khomeini St., Maryanaj
City
hamadan
Province
Hamadan
Postal code
6514144868
Phone
+98 81 3426 3597
Email
al.abdi@edu.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Abdi
Position
MSc student in Surgical technology
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No 110, Imam Khomeini St., Maryanaj
City
Hamadan
Province
Hamadan
Postal code
6514144868
Phone
+98 81 3426 3597
Email
alireza.abdi.st@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Title and more details about the data/document
In this study, it will find part of the same data as the information related to the main outcome, follow-ups, and background and demographic information of the participants with the aim of researching the publication.
When the data will become available and for how long
The beginning of the access period is from 2025
To whom data/document is available
The results of this study will be available for researchers working in academic and scientific institutions, surgeons, residents and nurses working in the clinical field.
Under which criteria data/document could be used
The use of documentation is allowed to improve the clinical knowledge of specialists and treatment staff
From where data/document is obtainable
To receive documents or get guidance, people can access the email of the person responsible for this study at the address below. Email address: al.abdi@edu.umsha.ac.ir
What processes are involved for a request to access data/document
The requester of these documents can send an email to the author of this study and while introducing himself and stating his purpose of requesting these documents, he can have them at the discretion of the authors.