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

Primary Purpose

Anesthesia, Carbon Dioxide, Surgical Blood Loss

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The amount of intraoperative bleeding
Quality of the intraoperative surgical field
Surgeon Satisfaction
Heart rate
Mean arterial pressure
Peripheral oxygen saturation
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Anesthesia management, Ent-tidal carbon dioxide, Bleeding, Quality of surgical field

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Muhittin Calim

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group Hypocapnia

Group Hypercapnia

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Heart rate
Heart rate is measured as beats/minute on the anesthesia monitor
Mean arterial pressure
Mean arterial pressure is measured as mmHg on the anesthesia monitor
Peripheral oxygen saturation
Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor

Full Information

First Posted
August 8, 2022
Last Updated
February 3, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05497375
Brief Title
EtCO2 Level to Control Intraoperative Bleeding and Improve the Quality of Surgical Field Vision in Septorhinoplasty
Acronym
EtCO2
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Carbon Dioxide, Surgical Blood Loss
Keywords
Anesthesia management, Ent-tidal carbon dioxide, Bleeding, Quality of surgical field

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Hypocapnia
Arm Type
Active Comparator
Arm 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.
Arm Title
Group Hypercapnia
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
The amount of intraoperative bleeding
Other Intervention Name(s)
Intraoperative bleeding
Intervention Description
Total amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.
Intervention Type
Diagnostic Test
Intervention Name(s)
Quality of the intraoperative surgical field
Other Intervention Name(s)
Quality of the surgical field
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Surgeon Satisfaction
Intervention Description
Surgeon Satisfaction will be measured on a grade of 0-5 (1= very bad, 2= bad, 3= moderate, 4= good, 5= very good).
Intervention Type
Diagnostic Test
Intervention Name(s)
Heart rate
Intervention Description
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Intervention Type
Diagnostic Test
Intervention Name(s)
Mean arterial pressure
Intervention Description
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Intervention Type
Diagnostic Test
Intervention Name(s)
Peripheral oxygen saturation
Intervention Description
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Primary Outcome Measure Information:
Title
Total amount of intraoperative bleeding
Description
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
Title
Quality of the intraoperative surgical field
Description
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
Title
Surgeon Satisfaction
Description
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 Outcome Measure Information:
Title
Heart rate
Description
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)
Title
Mean arterial pressure
Description
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)
Title
Peripheral oxygen saturation
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhittin Calim, MD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhittin Calim
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
26674898
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.
Results Reference
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EtCO2 Level to Control Intraoperative Bleeding and Improve the Quality of Surgical Field Vision in Septorhinoplasty

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