The Effect of Preoxygenation on Gastric Decompression in Laparoscopic Cholecystectomies

Aim: Gastric insufflation caused by mask ventilation during laparoscopic surgeries may affect the surgical field, lead to regurgitation of gastric contents, and consequently cause aspiration pneumonia. In this study, we aimed to investigate the effect of preoxygenation instead of mask ventilation in laparoscopic cholecystectomies (LC) on the need for decompression due to gastric insufflation, as well as its impact on postoperative sore throat and the presence of bleeding in aspiration in patients requiring an orogastric (OG) tube.

Materials and Methods: This single-center, prospective, observational study included 128 patients aged 18-65 years with ASA I-III undergoing LC surgery. After anesthesia induction, patients were divided into two groups: those ventilated with a mask (Group A, n=64) and those preoxygenated until their end-tidal oxygen (EtO₂) level exceeded 85% and not ventilated with a mask before induction (Group B, n=64). Anesthesia induction was performed in a standardized manner with appropriate doses for each patient. After administration of a muscle relaxant, patients were intubated by the same anesthesiologist following a 2-minute waiting period. The development of gastric insufflation, the need for OG tube placement, sore throat, and the presence of bleeding in aspiration were compared between the groups.

Study Overview

• Status: Completed
• Conditions: Cholelithiasis
• Intervention / Treatment: Procedure: Mask Ventilation; Procedure: Preoxygenation

Detailed Description

Exclusion criteria for participation in the study:

• Age under 18 or over 65 years,
• Patients who do not wish to participate in the study,
• Patients classified as ASA IV or V,
• History of difficult intubation.

Criteria for termination of study participation:

• Failure to perform endotracheal intubation on the first attempt
• Presence of difficult intubation
• Occurrence of oropharyngeal or laryngeal trauma during intubation

Expected Benefits and Risks of the Study:

We hypothesize that in the operating rooms of the Oncology Hospital at Ankara City Hospital, Ministry of Health of the Republic of Türkiye, preoxygenation instead of mask ventilation during general anesthesia for laparoscopic cholecystectomies may reduce gastric insufflation, potentially improve surgical comfort, and have a positive effect on postoperative sore throat caused by swallowing, since the use of orogastric tubes may no longer be necessary.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06800
      • University of Health Sciences (SBÜ) Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Scheduled to undergo laparoscopic cholecystectomy under general anesthesia

• Patients aged 18-65 years
• ASA physical status I, II, or III

Exclusion Criteria:

• Patients younger than 18 years or older than 65 years
• ASA physical status IV or V
• History of difficult intubation

Termination Criteria:

• Failure to achieve successful intubation on the first attempt
• Difficult intubation during the procedure
• Oropharyngeal or laryngeal trauma occurring during endotracheal intubation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ventilation Group (Group A); Patients who underwent mask ventilation after anaesthesia induction (Group A, n=64)	Procedure: Mask Ventilation; After anaesthesia induction, mask ventilation is administered until intubation, and preoxygenation is not performed.
Experimental: Preoxygenation Group (Group B); Those preoxygenated until their end-tidal oxygen (EtO₂) level exceeded 85% and not ventilated with a mask before induction (Group B, n=64)	Procedure: Preoxygenation; Patients in the preoxygenation group were preoxygenated prior to induction until EtO₂ >85%, and patients were intubated without mask ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Gastric Insufflation	The surgeon assessed the degree of gastric distension after trocar placement and creation of pneumoperitoneum with CO₂. If gastric insufflation was present, an orogastric (OG) tube was inserted in both groups.	Immediately after creation of pneumoperitoneum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Postoperative Sore Throat	After extubation, patients who were transferred to the postoperative recovery unit were asked about the presence and severity of sore throat during swallowing. Sore throat was scored as follows: 0 = no sore throat; = mild sore throat; = moderate sore throat; = severe sore throat	Postoperative 10 minutes
Presence of Blood During Suction at Extubation	The presence of blood during oropharyngeal suction was recorded at the time of extubation in both groups. The relationship between the use of an orogastric (OG) tube and the presence of blood during suction was evaluated.	During extubation
Postoperative presence of a blood smell in the mouth	The presence of a blood smell in the mouth was assessed in the postoperative recovery unit after extubation. Patients were asked whether they noticed a blood smell in the oral cavity during the early postoperative period.	Postoperative 10 minutes

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Orogastric tube; Laparoscopic Cholecystectomy; Preoxygenation; Postoperative Sore Throat; Gastric Decompression; Gastric Insufflation
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Cholelithiasis
• Other Study ID Numbers: EBRU-YURDAKUL-VURAL-ANKARA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No