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

Not Applicable

Completed

• Conditions: Anesthesia; Surgical Blood Loss; Carbon Dioxide
• Interventions: Diagnostic Test: The amount of intraoperative bleeding; Diagnostic Test: Quality of the intraoperative surgical field; Diagnostic Test: Surgeon Satisfaction; Diagnostic Test: Heart rate; Diagnostic Test: Mean arterial pressure; Diagnostic Test: Peripheral oxygen saturation

• Registration Number: NCT05497375
• Lead Sponsor: Bezmialem Vakif University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-08-20
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Hypocapnia	Surgeon Satisfaction	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.
Group Hypocapnia	Heart rate	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.
Group Hypocapnia	The amount of intraoperative bleeding	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.
Group Hypercapnia	The amount of intraoperative bleeding	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.
Group Hypercapnia	Quality of the intraoperative surgical field	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.
Group Hypocapnia	Quality of the intraoperative surgical field	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.
Group Hypercapnia	Mean arterial pressure	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.
Group Hypocapnia	Peripheral oxygen saturation	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.
Group Hypercapnia	Heart rate	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.
Group Hypercapnia	Surgeon Satisfaction	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.
Group Hypercapnia	Peripheral oxygen saturation	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.
Group Hypocapnia	Mean arterial pressure	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.

Primary Outcome Measures

Name	Time	Method
Quality of the intraoperative surgical field	Quality of the intraoperative surgical field will be performed to surgeon 30 minutes after the procedure	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)
Total amount of intraoperative bleeding	From beginning of surgery to end of surgery	Total amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.
Surgeon Satisfaction	Surgeon Satisfaction will be performed to surgeon 30 minutes after the procedure	Surgeon Satisfaction will be measured on a grade of 0-5 (1= very bad, 2= bad, 3= moderate, 4= good, 5= very good).

Secondary Outcome Measures

Name	Time	Method
Heart rate	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)	Heart rate is measured as beats/minute on the anesthesia monitor
Mean arterial pressure	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)	Mean arterial pressure is measured as mmHg on the anesthesia monitor
Peripheral oxygen saturation	From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)	Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor

Trial Locations

Locations (1)

Muhittin Calim; 🇹🇷 Istanbul, Fatih, Turkey