The Effect of Preoxygenation on Gastric Decompression in Laparoscopic Cholecystectomies

NCT07274488 | Completed

• 1 other identifier: EBRU-YURDAKUL-VURAL-ANKARA-001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholelithiasis

Keywords

Laparoscopic Cholecystectomy; Preoxygenation; Gastric Decompression; Gastric Insufflation; Postoperative Sore Throat; Orogastric tube

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Severity of Postoperative Sore Throat

  Postoperative 10 minutes

• Presence of Blood During Suction at Extubation

  During extubation

• Postoperative presence of a blood smell in the mouth

  Postoperative 10 minutes

Study Arms (2)

Ventilation Group (Group A)

ACTIVE COMPARATOR

Patients who underwent mask ventilation after anaesthesia induction (Group A, n=64)

Procedure: Mask Ventilation

Preoxygenation Group (Group B)

EXPERIMENTAL

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

Interventions

Preoxygenation PROCEDURE

Patients in the preoxygenation group were preoxygenated prior to induction until EtO₂ \>85%, and patients were intubated without mask ventilation.

Preoxygenation Group (Group B)

Mask Ventilation PROCEDURE

After anaesthesia induction, mask ventilation is administered until intubation, and preoxygenation is not performed.

Ventilation Group (Group A)

Eligibility Criteria

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

You may qualify if:

• Scheduled to undergo laparoscopic cholecystectomy under general anesthesia
• Patients aged 18-65 years
• ASA physical status I, II, or III

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

University of Health Sciences (SBÜ) Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

Related Links

• Related Info
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MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Randomized, Single-Blind Clinical Trial

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 10, 2025
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)