EtCO2 Level to Control Intraoperative Bleeding and Improve the Quality of Surgical Field Vision in Septorhinoplasty

Anesthesia Clinical Trial

— EtCO2  

Official title:

An Ideal End-tidal Carbon Dioxide Level to Control Intraoperative Bleeding and Improve the Quality of Surgical Field Vision in Septorhinoplasty Operations Under General Anesthesia: a Prospective Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05497375
• Other study ID #: muhittincalim3
• Status: Completed
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: February 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is unknown whether different end-tidal 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.

Description:

Septorhinoplasty is one of the most common esthetic surgeries in the world. The septorhinoplasty is accompanied by insignificant bleeding on the surgical field. Excessive bleeding compromises the surgical field quality and makes more difficult the septorhinoplasty. It is very important to control and minimize excessive bleeding in surgical field by different approaches of anesthesia management. Successful approaches to reduce the excessive bleeding are; controlled hypotension by keeping the mean arterial pressure in the range of 60-70 mmHg, the reverse Trendelenburg position of the patient, administration of adrenaline (injection prior to surgery or packing soaked during surgery), and administration of tranexamic acid, which are applicable methods in many clinical centers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists scores 1-3

• 18-65 years

Exclusion Criteria:

• American Society of Anesthesiologists scores IV,

• 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

Related Conditions & MeSH terms

• Anesthesia
• Blood Loss, Surgical
• Carbon Dioxide
• Hemorrhage
• Surgical Blood Loss

Intervention

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
Turkey	Muhittin Calim	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of intraoperative bleeding	Total amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.	From beginning of surgery to end of surgery
Primary	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)	Quality of the intraoperative surgical field will be performed to surgeon 30 minutes after the procedure
Primary	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).	Surgeon Satisfaction will be performed to surgeon 30 minutes after the procedure
Secondary	Heart rate	Heart rate is measured as beats/minute on the anesthesia monitor	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Secondary	Mean arterial pressure	Mean arterial pressure is measured as mmHg on the anesthesia monitor	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Secondary	Peripheral oxygen saturation	Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)