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CompletedNCT05497375EtCO2Updated Feb 6, 2023

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

An interventional study of The amount of intraoperative bleeding and Quality of the intraoperative surgical field in Anesthesia, Carbon Dioxide and Surgical Blood Loss, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-06.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia
  • Carbon Dioxide
  • Surgical Blood Loss

Keywords

  • Anesthesia management
  • Ent-tidal carbon dioxide
  • Bleeding
  • Quality of surgical field
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 70 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • American Society of Anesthesiologists scores 1-3
  • 18-65 years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Group Hypocapnia

    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.

    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

  • Active comparator
    Group Hypercapnia

    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.

    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

Interventions

  • Diagnostic testThe amount of intraoperative bleeding

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

    Also known as: Intraoperative bleeding

  • 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)

    Also known as: Quality of the surgical field

  • 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)

  • Diagnostic testPeripheral oxygen saturation

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

06

What researchers measure

Primary outcomes

  1. Total amount of intraoperative bleeding

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

    Time frame: From beginning of surgery to end of surgery

  2. Quality 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)

    Time frame: Quality of the intraoperative surgical field will be performed to surgeon 30 minutes after the procedure

  3. Surgeon Satisfaction

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

    Time frame: Surgeon Satisfaction will be performed to surgeon 30 minutes after the procedure

Secondary outcomes

  1. Heart rate

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

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

  2. Mean arterial pressure

    Mean arterial pressure is measured as mmHg on the anesthesia monitor

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

  3. Peripheral oxygen saturation

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

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

07

Study locations

1 site
  • Muhittin Calim
    Istanbul, Fatih 34093, Turkey
08

References and documents

Publications

  • 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. PubMed 26674898 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05497375
Lead sponsor
Bezmialem Vakif University
Responsible party
Muhittin Calim (Principal Investigator, Bezmialem Vakif University) — Principal investigator
First posted
Aug 11, 2022
Start date
Aug 20, 2022
Primary completion
Nov 15, 2022
Completion
Nov 15, 2022
Last update
Feb 6, 2023

Study contacts

Muhittin Calim, MD
principal investigator · Bezmialem Vakif University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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