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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05497375
Acronym
EtCO2
Enrollment
70
Registered
2022-08-11
Start date
2022-08-20
Completion date
2022-11-15
Last updated
2023-02-06

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

Conditions

Anesthesia, Carbon Dioxide, Surgical Blood Loss

Keywords

Anesthesia management, Ent-tidal carbon dioxide, Bleeding, Quality of surgical field

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.

Interventions

DIAGNOSTIC_TESTThe amount of intraoperative bleeding

Total amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.

DIAGNOSTIC_TESTQuality 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)

DIAGNOSTIC_TESTSurgeon Satisfaction

Surgeon Satisfaction will be measured on a grade of 0-5 (1= very bad, 2= bad, 3= moderate, 4= good, 5= very good).

DIAGNOSTIC_TESTHeart rate

From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

DIAGNOSTIC_TESTMean arterial pressure

From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total amount of intraoperative bleedingFrom beginning of surgery to end of surgeryTotal amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.
Quality of the intraoperative surgical fieldQuality of the intraoperative surgical field will be performed to surgeon 30 minutes after the procedureQuality 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 SatisfactionSurgeon Satisfaction will be performed to surgeon 30 minutes after the procedureSurgeon Satisfaction will be measured on a grade of 0-5 (1= very bad, 2= bad, 3= moderate, 4= good, 5= very good).

Secondary

MeasureTime frameDescription
Heart rateFrom 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 pressureFrom 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 saturationFrom beginning of Anesthesia induction to the end of anesthesia (during perioperative period)Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026