AnesthesiaEtCO2NCT05497375
EtCO2 Level to Control Intraoperative Bleeding and Improve the Quality of Surgical Field Vision in Septorhinoplasty
A study testing The amount of intraoperative bleeding, Quality of the intraoperative surgical field and Surgeon Satisfaction in people with Anesthesia and Carbon Dioxide, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Carbon Dioxide, Surgical Blood Loss
- What is being tested?
- The amount of intraoperative bleeding, Quality of the intraoperative surgical field and Surgeon Satisfaction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2022to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists scores 1-3
- 18-65 years
Who cannot join
- 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,
Show all 10Show fewer
- Cardiovascular and pulmonary disease,
- Uncontrolled cerebrovascular disease,
- Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and tramadol,
- Refused written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Anesthesia, Carbon Dioxide, Surgical Blood Loss
- Being tested
- The amount of intraoperative bleeding, Quality of the intraoperative surgical field, Surgeon Satisfaction, Heart rate, Mean arterial pressure
- Keywords
- Anesthesia management, Ent-tidal carbon dioxide, Bleeding, Quality of surgical field
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The amount of intraoperative bleedingDiagnostic test
Also called Intraoperative bleeding
Total amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.
Quality of the intraoperative surgical fieldDiagnostic test
Also called Quality of the 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 SatisfactionDiagnostic 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 rateDiagnostic test
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressureDiagnostic test
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturationDiagnostic test
From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
| Study group | Role | What they receive |
|---|---|---|
| Group Hypocapnia | Active comparator | 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. Receives: 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 |
| Group Hypercapnia | Active comparator | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of intraoperative bleeding
Total amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.
Measured: From beginning of surgery to 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)
Measured: Quality of the intraoperative surgical field will be performed to surgeon 30 minutes after the procedure
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).
Measured: Surgeon Satisfaction will be performed to surgeon 30 minutes after the procedure
Secondary outcomes (3)
Heart rate
Heart rate is measured as beats/minute on the anesthesia monitor
Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
Mean arterial pressure is measured as mmHg on the anesthesia monitor
Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
Peripheral oxygen saturation is measured as percentage (%) on the anesthesia monitor
Measured: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start20 Aug 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhittin Calim, Bezmialem Vakif University
- Investigators
- Muhittin Calim, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497375
- Sponsor's protocol ID
- muhittincalim3
- Acronym
- EtCO2
- Status last verified
- Feb 2023
- First submitted
- 8 Aug 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 26674898Calim M, Karaaslan K, Yilmaz S, Senturk E, Deniz H, Akbas S. The Effects of Hypocapnia and Hypercapnia on Intraoperative Bleeding, Surgical Field Quality, and Surgeon Satisfaction Level in Septorhinoplasty: A Prospective Randomized Clinical Study. Aesthetic Plast Surg. 2024 Jan;48(2):167-176. doi: 10.1007/s00266-023-03433-9. Epub 2023 Jul 5.
PubMed 37407709
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05497375
- Acronym / sponsor ID
- EtCO2 / muhittincalim3
- Conditions
- Anesthesia, Carbon Dioxide, Surgical Blood Loss
- Keywords
- Anesthesia management, Ent-tidal carbon dioxide, Bleeding, Quality of surgical field
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Hypocapnia | Active comparator | 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 saturationEnd-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. |
| Group Hypercapnia | Active comparator | 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 saturationEnd-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists scores 1-3
- 18-65 years
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The amount of intraoperative bleedingAlso: Intraoperative bleedingTotal amount of intraoperative bleeding will be calculated in milliliters after the end of surgery. | Diagnostic test | Group Hypercapnia, Group Hypocapnia |
| Quality of the intraoperative surgical fieldAlso: Quality of the surgical fieldQuality 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 test | Group Hypercapnia, Group Hypocapnia |
| Surgeon SatisfactionSurgeon Satisfaction will be measured on a grade of 0-5 (1= very bad, 2= bad, 3= moderate, 4= good, 5= very good). | Diagnostic test | Group Hypercapnia, Group Hypocapnia |
| Heart rateFrom beginning of Anesthesia induction to the end of anesthesia (during perioperative period) | Diagnostic test | Group Hypercapnia, Group Hypocapnia |
| Mean arterial pressureFrom beginning of Anesthesia induction to the end of anesthesia (during perioperative period) | Diagnostic test | Group Hypercapnia, Group Hypocapnia |
| Peripheral oxygen saturationFrom beginning of Anesthesia induction to the end of anesthesia (during perioperative period) | Diagnostic test | Group Hypercapnia, Group Hypocapnia |
Primary outcome
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.
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)
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).
3 secondary outcomes
Heart rate
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Mean arterial pressure
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Peripheral oxygen saturation
Time frame: From beginning of Anesthesia induction to the end of anesthesia (during perioperative period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Background: PubMed 26674898Eftekharian 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.
- Derived from this study: PubMed 37407709Calim M, Karaaslan K, Yilmaz S, Senturk E, Deniz H, Akbas S. The Effects of Hypocapnia and Hypercapnia on Intraoperative Bleeding, Surgical Field Quality, and Surgeon Satisfaction Level in Septorhinoplasty: A Prospective Randomized Clinical Study. Aesthetic Plast Surg. 2024 Jan;48(2):167-176. doi: 10.1007/s00266-023-03433-9. Epub 2023 Jul 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhittin Calim, MD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The amount of intraoperative bleeding, Quality of the intraoperative surgical field and Surgeon Satisfaction in people with Anesthesia and Carbon Dioxide, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of intraoperative bleeding (time frame: From beginning of surgery to end of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497375, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.