Effect of Mask Ventilation on Surgical Field View in Robotic Colorectal Surgery
NCT ID: NCT07097129
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-08-01
2025-10-20
Brief Summary
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How will non-mask ventilation during anaesthesia induction effect surgical vision in robotic colorectal surgeries compared to mask ventilation? How will non-mask ventilation during anaesthesia induction effect gastric dilatation and bowel movements in robotic colorectal surgeries compared to mask ventilation?
If there is a comparison group: Researchers will compare mask ventilation and non-mask ventilation during anaesthesia induction to see if the surgical vision, gastric dilatation and bowel movements are effected.
Participants will be divided in two groups:
No mask ventilation group: Outside of spontaneous breathing during preoxygenation, orotracheal intubation will be performed at the 60th second after anesthesia induction without ventilation, using video laryngoscopy. Mask ventilation group: After anesthesia induction, mask ventilation will be performed with a respiratory rate of 10 and 15 cmH2O pressure, followed by orotracheal intubation using video laryngoscopy at the 60th second.
Researchers will compare the results between the groups to see the surgical vision, gastric dilatation and bowel movements.
The hypothesis of this study is that non-mask ventilation will provide better surgical vision, less gastric dilatation and less bowel movements in robotic colorectal surgeries.
Detailed Description
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In our anaesthesia practice, patients will be premedicated with 0.03 mg/kg midazolam in the preoperative area and then taken to the operating room. After standard monitorization in the operating room, preoxygenation will be applied with end tidal oxygen (EtO2) monitoring. Patients whose EtO2 value reached 90% will be divided into two groups and the following protocol will be applied; No mask ventilation group: 2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anaesthesia induction. Orotracheal intubation will be performed at 60 seconds with video laryngoscopy without ventilation other than spontaneous breathing.
Mask ventilation group: 2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anesthesia induction. Mask ventilation will be performed with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute. Orotracheal intubation will be performed at the 60th second with video laryngoscopy.
The surgical team, who is blinded to the anesthesia induction groups, will mark the Likert scale prepared for the presence of gastric distension, presence of intestinal distension, status of bowel movements and surgical vision regarding the intraoperative process. Surgical time will also be recorded at the end of the operation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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No Mask Ventilation
2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anaesthesia induction. Orotracheal intubation will be performed at 60 seconds with video laryngoscopy without ventilation other than spontaneous breathing.
Mask Ventilation
Mask ventilation with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute
Mask Ventilation
2 mcg/kg fentanyl, 1 - 2 mg/kg propofol, 1 mg/kg rocuronium will be administered for anaesthesia induction. Mask ventilation will be performed with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute. Orotracheal intubation will be performed at the 60th second with video laryngoscopy.
No interventions assigned to this group
Interventions
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Mask Ventilation
Mask ventilation with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Presence of restrictive/obstructive lung disease requiring CPAP application for treatment in preoperative anaesthesia evaluation
* Patients with cardiovascular diseases (EF \< 20%, advanced aortic stenosis, decompensated heart failure) that require change of at least one of the drugs to be used for anaesthesia induction
* Presence of allergy to any of the drugs to be used in anaesthesia induction and maintenance
18 Years
80 Years
ALL
No
Sponsors
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Koç University
OTHER
Responsible Party
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Kamil Darcin
MD
Locations
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Koç University Hospital
Istanbul, Zeytinburnu, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Kamil Darçın
Role: primary
References
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Jung YK, Kim CL, Jeong MA, Sung JM, Lee KG, Kim NY, Kang L, Lim H. Gastric insufflation and surgical view according to mask ventilation method for laparoscopic cholecystectomy: a randomized controlled study. BMC Anesthesiol. 2023 Sep 20;23(1):321. doi: 10.1186/s12871-023-02269-9.
Bouvet L, Albert ML, Augris C, Boselli E, Ecochard R, Rabilloud M, Chassard D, Allaouchiche B. Real-time detection of gastric insufflation related to facemask pressure-controlled ventilation using ultrasonography of the antrum and epigastric auscultation in nonparalyzed patients: a prospective, randomized, double-blind study. Anesthesiology. 2014 Feb;120(2):326-34. doi: 10.1097/ALN.0000000000000094.
Other Identifiers
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2024.286.IRB1.036
Identifier Type: -
Identifier Source: org_study_id