CholelithiasisNCT07274488
The Effect of Preoxygenation on Gastric Decompression in Laparoscopic Cholecystectomies
A study testing Preoxygenation and Mask Ventilation in people with Cholelithiasis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Preoxygenation and Mask Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo laparoscopic cholecystectomy under general anesthesia
- Patients aged 18-65 years
- ASA physical status I, II, or III
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences (SBÜ) Ankara Bilkent City Hospital
Ankara, Ankara, 06800
About this study
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.
Read the 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
- Being tested
- Preoxygenation, Mask Ventilation
- Keywords
- Laparoscopic Cholecystectomy, Preoxygenation, Gastric Decompression, Gastric Insufflation, Postoperative Sore Throat, Orogastric tube
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreoxygenationProcedure or surgery
Patients in the preoxygenation group were preoxygenated prior to induction until EtO₂ >85%, and patients were intubated without mask ventilation.
Mask VentilationProcedure or surgery
After anaesthesia induction, mask ventilation is administered until intubation, and preoxygenation is not performed.
| Study group | Role | What they receive |
|---|---|---|
| Ventilation Group (Group A) | Active comparator | Patients who underwent mask ventilation after anaesthesia induction (Group A, n=64) Receives: Procedure: Mask Ventilation |
| Preoxygenation Group (Group B) | Experimental | Those preoxygenated until their end-tidal oxygen (EtO₂) level exceeded 85% and not ventilated with a mask before induction (Group B, n=64) Receives: Procedure: Preoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Gastric Insufflation
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.
Measured: Immediately after creation of pneumoperitoneum
Secondary outcomes (3)
Severity of Postoperative Sore Throat
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
- = mild sore throat
- = moderate sore throat
- = severe sore throat
Measured: Postoperative 10 minutes
Presence of Blood During Suction at 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.
Measured: During extubation
Postoperative presence of a blood smell in the mouth
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.
Measured: Postoperative 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Feb 2024
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, Single-Blind Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274488
- Sponsor's protocol ID
- EBRU-YURDAKUL-VURAL-ANKARA-001
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoxygenation on Gastric Decompression in Laparoscopic Cholecystectomies
- ClinicalTrials.gov ID
- NCT07274488
- Acronym / sponsor ID
- EBRU-YURDAKUL-VURAL-ANKARA-001
- Conditions
- Cholelithiasis
- Keywords
- Laparoscopic Cholecystectomy, Preoxygenation, Gastric Decompression, Gastric Insufflation, Postoperative Sore Throat, Orogastric tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Single-Blind Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Ventilation Group (Group A) | Active comparator | Procedure: Mask VentilationPatients who underwent mask ventilation after anaesthesia induction (Group A, n=64) |
| Preoxygenation Group (Group B) | Experimental | Procedure: PreoxygenationThose preoxygenated until their end-tidal oxygen (EtO₂) level exceeded 85% and not ventilated with a mask before induction (Group B, n=64) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo laparoscopic cholecystectomy under general anesthesia
- Patients aged 18-65 years
- ASA physical status I, II, or III
Key exclusion criteria (7 listed)
- Patients younger than 18 years or older than 65 years
- ASA physical status IV or V
- History of difficult intubation
- Failure to achieve successful intubation on the first attempt
- Difficult intubation during the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreoxygenationPatients in the preoxygenation group were preoxygenated prior to induction until EtO₂ >85%, and patients were intubated without mask ventilation. | Procedure or surgery | Preoxygenation Group (Group B) |
| Mask VentilationAfter anaesthesia induction, mask ventilation is administered until intubation, and preoxygenation is not performed. | Procedure or surgery | Ventilation Group (Group A) |
Primary outcome
Presence of Gastric Insufflation
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.
3 secondary outcomes
Severity of Postoperative Sore Throat
Time frame: Postoperative 10 minutes
Presence of Blood During Suction at Extubation
Time frame: During extubation
Postoperative presence of a blood smell in the mouth
Time frame: Postoperative 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cholelithiasis
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoxygenation and Mask Ventilation in people with Cholelithiasis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Gastric Insufflation (time frame: Immediately after creation of pneumoperitoneum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.