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Comparison of total intravenous anesthesia(TIVA) with propofol and inhalation anesthesia with isoflurane in patients undergoing posterior lumbar fusion surgery

Comparison of total intravenous anesthesia(TIVA) with propofol and inhalation anesthesia with isoflurane in patients undergoing posterior lumbar fusion surgery: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230208057358N2
Enrollment
66
Registered
2024-08-13
Start date
2024-08-20
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Lumbar spinal stenosis. Condition 2: complications of total intravenous anaesthesia. Condition 3: complications of inhalation anesthesia. Spinal stenosis, lumbosacral region Other complications of anesthesia Other complications of anesthesia

Interventions

Intervention 1: 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 s

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.;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.;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.;The amount of opioid analgesic received after surgery. Timepoint: At the time of discharge from the hospital. Method of measurement: Injection syringe (in milliliters).;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).;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.;Extubation time. Timepoint: Immediately a

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Abdi

Hamedan University of Medical Sciences

alireza.abdi.st@gmail.com+98 81 3426 3597

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026