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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.
Following anaesthesia induction, mask ventilation is a technique applied until successful tracheal intubation is achieved. It is known that with mask ventilation, air can also enter the stomach as well as the trachea. If mask ventilation is not performed with the correct technique during robotic surgery, excessive dilation of the stomach will impair the surgical team's vision, causing the operation to be more difficult and longer. In this study, we aimed to demonstrate the effects of mask ventilation and non-mask ventilation on gastric dilatation, increased bowel movements, bowel distension and surgical vision in robotic colorectal surgeries.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mask Ventilation | Procedure | Mask ventilation with mechanical ventilator set to pressure controlled ventilation, 15 cmH20 peak pressure, 10 respiratory rates per minute |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koç University Hospital | Istanbul | Zeytinburnu | 34010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37730575 | Background | 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. | |
| 24317204 | 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. |
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Starting from 6 months after publication for 5 years
No access criteria
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| ID | Term |
|---|---|
| D013271 | Gastric Dilatation |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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.