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

B

Bezmialem Vakif University

Status

Completed

Conditions

Surgical Blood Loss
Carbon Dioxide
Anesthesia

Treatments

Diagnostic Test: The amount of intraoperative bleeding
Diagnostic Test: Peripheral oxygen saturation
Diagnostic Test: Quality of the intraoperative surgical field
Diagnostic Test: Heart rate
Diagnostic Test: Surgeon Satisfaction
Diagnostic Test: Mean arterial pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT05497375
muhittincalim3

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Group Hypocapnia
Active Comparator group
Description:
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.
Treatment:
Diagnostic Test: Peripheral oxygen saturation
Diagnostic Test: Mean arterial pressure
Diagnostic Test: Surgeon Satisfaction
Diagnostic Test: Heart rate
Diagnostic Test: Quality of the intraoperative surgical field
Diagnostic Test: The amount of intraoperative bleeding
Group Hypercapnia
Active Comparator group
Description:
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.
Treatment:
Diagnostic Test: Peripheral oxygen saturation
Diagnostic Test: Mean arterial pressure
Diagnostic Test: Surgeon Satisfaction
Diagnostic Test: Heart rate
Diagnostic Test: Quality of the intraoperative surgical field
Diagnostic Test: The amount of intraoperative bleeding

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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