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Completed

NCT Number: NCT05497375

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muhittin Calim

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The amount of intraoperative bleeding

Diagnostic Test

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

Other names: Intraoperative bleeding

Quality of the intraoperative surgical field

Diagnostic Test

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)

Other names: Quality of the surgical field

Surgeon Satisfaction

Diagnostic Test

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

Diagnostic Test

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

Mean arterial pressure

Diagnostic Test

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

Peripheral oxygen saturation

Diagnostic Test

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

Primary outcomes

  1. Total amount of intraoperative bleeding

    Time frame: From beginning of surgery to end of surgery

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

  2. Quality of the intraoperative surgical field

    Time frame: 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)

  3. Surgeon Satisfaction

    Time frame: 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 outcomes

  1. Heart rate

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

    Heart rate is measured as beats/minute on the anesthesia monitor

  2. Mean arterial pressure

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

    Mean arterial pressure is measured as mmHg on the anesthesia monitor

  3. Peripheral oxygen saturation

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

    Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study 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

Acronym: EtCO2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 11, 2022
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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