Cholelithiasis
Conditions
Keywords
Laparoscopic Cholecystectomy, Preoxygenation, Gastric Decompression, Gastric Insufflation, Postoperative Sore Throat, Orogastric tube
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.
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.
Interventions
PROCEDUREPreoxygenation
Patients in the preoxygenation group were preoxygenated prior to induction until EtO₂ \>85%, and patients were intubated without mask ventilation.
PROCEDUREMask Ventilation
After anaesthesia induction, mask ventilation is administered until intubation, and preoxygenation is not performed.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Prospective, Randomized, Single-Blind Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Gastric Insufflation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Postoperative Sore Throat | 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 1. = mild sore throat 2. = moderate sore throat 3. = severe sore throat |
| Presence of Blood During Suction at Extubation | 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. |
| Postoperative presence of a blood smell in the mouth | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed