University of Health Sciences (SBÜ) Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
NCT Number: NCT07274488
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Ankara, 06800, Turkey (Türkiye)
Exclusion criteria
for participation in the study:
Criteria for termination of study participation:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Scheduled to undergo laparoscopic cholecystectomy under general anesthesia
Exclusion criteria
Termination Criteria:
Patients in the preoxygenation group were preoxygenated prior to induction until EtO₂ >85%, and patients were intubated without mask ventilation.
After anaesthesia induction, mask ventilation is administered until intubation, and preoxygenation is not performed.
Time frame: Immediately after creation of pneumoperitoneum
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.
Time frame: Postoperative 10 minutes
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
Time frame: During 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.
Time frame: Postoperative 10 minutes
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.
Ankara City Hospital Bilkent
Other
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