The Effect of Preoxygenation on Gastric Decompression in Laparoscopic Cholecystectomies
NCT ID: NCT07274488
Last Updated: 2025-12-10
Study Results
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Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2024-02-01
2024-08-01
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Ventilation Group (Group A)
Patients who underwent mask ventilation after anaesthesia induction (Group A, n=64)
Mask Ventilation
After anaesthesia induction, mask ventilation is administered until intubation, and preoxygenation is not performed.
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)
Preoxygenation
Patients in the preoxygenation group were preoxygenated prior to induction until EtO₂ \>85%, and patients were intubated without mask ventilation.
Interventions
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Preoxygenation
Patients in the preoxygenation group were preoxygenated prior to induction until EtO₂ \>85%, and patients were intubated without mask ventilation.
Mask Ventilation
After anaesthesia induction, mask ventilation is administered until intubation, and preoxygenation is not performed.
Eligibility Criteria
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Inclusion Criteria
* Patients aged 18-65 years
* ASA physical status I, II, or III
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Locations
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University of Health Sciences (SBÜ) Ankara Bilkent City Hospital
Ankara, Ankara, Turkey (Türkiye)
Countries
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Related Links
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Related Info
Related Info
Other Identifiers
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EBRU-YURDAKUL-VURAL-ANKARA-001
Identifier Type: -
Identifier Source: org_study_id
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