NCT05497375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

August 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

August 8, 2022

Last Update Submit

February 3, 2023

Conditions

AnesthesiaCarbon DioxideSurgical Blood Loss

Keywords

Anesthesia managementEnt-tidal carbon dioxideBleedingQuality of surgical field

Outcome Measures

Primary Outcomes (3)

  • Total amount of intraoperative bleeding

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

    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)

    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).

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

Secondary Outcomes (3)

  • Heart rate

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

  • Mean arterial pressure

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

  • Peripheral oxygen saturation

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

Study Arms (2)

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.

Diagnostic Test: The amount of intraoperative bleedingDiagnostic Test: Quality of the intraoperative surgical fieldDiagnostic Test: Surgeon SatisfactionDiagnostic Test: Heart rateDiagnostic Test: Mean arterial pressureDiagnostic 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.

Diagnostic Test: The amount of intraoperative bleedingDiagnostic Test: Quality of the intraoperative surgical fieldDiagnostic Test: Surgeon SatisfactionDiagnostic Test: Heart rateDiagnostic Test: Mean arterial pressureDiagnostic Test: Peripheral oxygen saturation

Interventions

The amount of intraoperative bleedingDIAGNOSTIC_TEST

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

Also known as: Intraoperative bleeding
Group HypercapniaGroup Hypocapnia
Quality of the intraoperative surgical fieldDIAGNOSTIC_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)

Also known as: Quality of the surgical field
Group HypercapniaGroup Hypocapnia
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).

Group HypercapniaGroup Hypocapnia
Heart rateDIAGNOSTIC_TEST

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

Group HypercapniaGroup Hypocapnia
Mean arterial pressureDIAGNOSTIC_TEST

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

Group HypercapniaGroup Hypocapnia
Peripheral oxygen saturationDIAGNOSTIC_TEST

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

Group HypercapniaGroup Hypocapnia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists scores 1-3
  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhittin Calim

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 26674898BACKGROUND

  • Calim 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.

    PMID: 37407709DERIVED

MeSH Terms

Conditions

Blood Loss, SurgicalHemorrhage

Interventions

Heart RateArterial PressureOxygen Saturation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaBlood PressureMetabolism

Study Officials

  • Muhittin Calim, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 11, 2022

Study Start

August 20, 2022

Primary Completion

November 15, 2022

Study Completion

November 15, 2022

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

TU(1)