EtCO2 Level to Control Intraoperative Bleeding and Improve the Quality of Surgical Field Vision in Septorhinoplasty
NCT ID: NCT05497375
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2022-08-20
2022-11-15
Brief Summary
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Detailed Description
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Cardiac output may vary depending on the autonomic nervous system. The dominance of parasympathetic system effect may cause vasodilation, decrease in blood pressure and cardiac output. This vasodilation may increase bleeding during septorhinoplasty and worsen the surgical field quality. Anesthesia management may provide a clear view for the surgeon and an improved surgical field quality. The effect of carbon dioxide on vascular reactivity deserves an extra attention in septorhinoplasty required bleeding control. The intensity of bleeding in septorhinoplasty is mainly affected by mean arterial pressure and heart rate. At the same time, blood flow can be affected directly by carbon dioxide on the smooth muscular tonus of the arterioles.
After all, it is unknown whether different carbon dioxide pressure levels have a clinically significant effect on bleeding and surgical field quality in septorhinoplasty, especially during controlled hypotension. Therefore, it was aimed to investigate the effect of ventilation strategy with controlled hypocapnia on intraoperative bleeding and surgical field quality for commonly practiced in septorhinoplasty.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group Hypocapnia
End-tidal carbon dioxide level will be 30±2 mmHg in the capnography, and the respiratory rate will be 14-20/minutes in the hypocapnia group.
The amount of intraoperative bleeding
Total amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.
Quality of the intraoperative surgical field
Quality of the intraoperative surgical field will be measured on a grade of 0-10 (0-1. no bleeding, 2-3. mild bleeding, 4-5. Mild to moderate bleeding, 6-7. moderate bleeding, 8-9. moderate to severe bleeding, 10. Severe bleeding)
Surgeon Satisfaction
Surgeon Satisfaction will be measured on a grade of 0-5 (1= very bad, 2= bad, 3= moderate, 4= good, 5= very good).
Heart rate
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Group Hypercapnia
End-tidal carbon dioxide level will be 40±2 mmHg in the capnography, and the respiratory rate will be 10-14/minutes in the hypercapnia group.
The amount of intraoperative bleeding
Total amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.
Quality of the intraoperative surgical field
Quality of the intraoperative surgical field will be measured on a grade of 0-10 (0-1. no bleeding, 2-3. mild bleeding, 4-5. Mild to moderate bleeding, 6-7. moderate bleeding, 8-9. moderate to severe bleeding, 10. Severe bleeding)
Surgeon Satisfaction
Surgeon Satisfaction will be measured on a grade of 0-5 (1= very bad, 2= bad, 3= moderate, 4= good, 5= very good).
Heart rate
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Interventions
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The amount of intraoperative bleeding
Total amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.
Quality of the intraoperative surgical field
Quality of the intraoperative surgical field will be measured on a grade of 0-10 (0-1. no bleeding, 2-3. mild bleeding, 4-5. Mild to moderate bleeding, 6-7. moderate bleeding, 8-9. moderate to severe bleeding, 10. Severe bleeding)
Surgeon Satisfaction
Surgeon Satisfaction will be measured on a grade of 0-5 (1= very bad, 2= bad, 3= moderate, 4= good, 5= very good).
Heart rate
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-65 years
Exclusion Criteria
* Under the age of 18,
* Over the age of 65,
* Using anticoagulant and antiplatelet drugs,
* Previous underwent septorhinoplasty operation,
* Obstetric conditions,
* Cardiovascular and pulmonary disease,
* Uncontrolled cerebrovascular disease,
* Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and tramadol,
* Refused written informed consent
18 Years
65 Years
ALL
No
Sponsors
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Bezmialem Vakif University
OTHER
Responsible Party
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Muhittin Calim
Principal Investigator
Principal Investigators
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Muhittin Calim, MD
Role: PRINCIPAL_INVESTIGATOR
Bezmialem Vakif University
Locations
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Muhittin Calim
Istanbul, Fatih, Turkey (Türkiye)
Countries
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References
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Eftekharian HR, Rajabzadeh Z. The Efficacy of Preoperative Oral Tranexamic Acid on Intraoperative Bleeding During Rhinoplasty. J Craniofac Surg. 2016 Jan;27(1):97-100. doi: 10.1097/SCS.0000000000002273.
Other Identifiers
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muhittincalim3
Identifier Type: -
Identifier Source: org_study_id
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