Clinical trial NCT05497375: EtCO2 Level to Control Intraoperative Bleeding and Improve the Quality of Surgical Field Vision in Septorhinoplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Carbon Dioxide
Surgical Blood Loss
Keywords: Anesthesia management
Ent-tidal carbon dioxide
Bleeding
Quality of surgical field
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total amount of intraoperative bleeding
timeFrame: From beginning of surgery to end of surgery
measure: Quality of the intraoperative surgical field
timeFrame: Quality of the intraoperative surgical field will be performed to surgeon 30 minutes after the procedure
measure: Surgeon Satisfaction
timeFrame: Surgeon Satisfaction will be performed to surgeon 30 minutes after the procedure
Secondary outcomes:
measure: Heart rate
timeFrame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
measure: Mean arterial pressure
timeFrame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
measure: Peripheral oxygen saturation
timeFrame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Muhittin Calim
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Muhittin Calim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.