NCT07274488

The Effect of Preoxygenation on Gastric Decompression in Laparoscopic Cholecystectomies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cholelithiasis

Interventions

Type	Name	Description
PROCEDURE	Preoxygenation	Patients in the preoxygenation group were preoxygenated prior to induction until EtO₂ \>85%, and patients were intubated without mask ventilation.
PROCEDURE	Mask Ventilation	After anaesthesia induction, mask ventilation is administered until intubation, and preoxygenation is not performed.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2025-12-10
• Last updated: 2025-12-10

Locations

1 site across 1 country: Turkey (Türkiye)