The Effect of Preoxygenation on Gastric Decompression in Laparoscopic Cholecystectomies

Ankara City Hospital

Status: Completed

Conditions: Cholelithiasis

Treatments: Procedure: Mask Ventilation; Procedure: Preoxygenation

Study type: Interventional

Funder types: Other

Identifiers

NCT07274488

EBRU-YURDAKUL-VURAL-ANKARA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Ventilation Group (Group A)

Active Comparator group

Description:

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

Treatment:

Procedure: Mask Ventilation

Preoxygenation Group (Group B)

Experimental group

Description:

Those preoxygenated until their end-tidal oxygen (EtO₂) level exceeded 85% and not ventilated with a mask before induction (Group B, n=64)

Treatment:

Procedure: Preoxygenation