Effect of Mask Ventilation on Surgical Field View in Robotic Colorectal Surgery

NCT07097129 | Completed

• 1 other identifier: 2024.286.IRB1.036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to demonstrate the effects of pressure-controlled mask ventilation and non-mask ventilation during anaesthesia induction on gastric insufflation, gastric dilatation, increased bowel movements and bowel distension and to demonstrate its effect on surgical vision in robotic colorectal surgeries. The main questions it aims to answer are: 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.

Conditions

Bowel Distention; Surgical Procedure, Unspecified; Gastric Dilation

Keywords

robotic colorectal surgery; gastric dilation; bowel distention; surgical view

Outcome Measures

Primary Outcomes (4)

• Surgical Vision

  Likert scale Surgical field visibility is very poor: 1 point Surgical field visibility is poor: 2 points Surgical field visibility is moderate: 3 points Surgical field visibility is good: 4 points Surgical field visibility is very good: 5 points Higher scores on this scale mean a better outcome.

  5 minutes after the end of the surgical procedure

• Gastric Dilatation

  Likert Scale Gastric dilatation was severe enough to complicate the surgical technique: 1 point Gastric dilatation was present but did not complicate the surgery: 2 points Stomach was not dilated: 3 points Higher scores on this scale mean a better outcome.

  5 minutes after the end of the surgical procedure

• Bowel distension

  Likert Scale Bowel distension is quite significant: 1 point Bowel distension is significant: 2 points Bowel distension is moderate: 3 points Bowel distension is mild: 4 points No bowel distension: 5 points Higher scores on this scale mean a better outcome.

  5 minutes after the end of the surgical procedure

• Bowel movement

  Likert Scale Bowel movements are quite frequent: 1 point Bowel movements are frequent: 2 points Bowel movements are moderate: 3 points Bowel movements are mild: 4 points No bowel movements: 5 points Higher scores on this scale mean a better outcome.

  5 minutes after the end of the surgical procedure

Study Arms (2)

No Mask Ventilation

ACTIVE COMPARATOR

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.

Procedure: Mask Ventilation

Mask Ventilation

NO INTERVENTION

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.

Interventions

Mask Ventilation PROCEDURE

Mask ventilation with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute

No Mask Ventilation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18 and 80 who are scheduled to undergo robotic colorectal surgery will be included in the study.

You may not qualify if:

• Patients with preoperative prediction of possible difficult intubation
• 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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koç University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 37730575 BACKGROUND

• 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.

  PMID: 24317204 BACKGROUND

MeSH Terms

Conditions

Gastric Dilatation

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The surgical team, who is blinded to the anaesthesia 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 20, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting from 6 months after publication for 5 years
• Access Criteria: No access criteria

Locations

TU (1)