Comparison of the effect of positional changes and administration of N2O on pain, nausea and vomiting in pneumoperitoneal method with CO2 after laparoscopic cholecystectomy (A double-blind clinical trial study)

Comparison of the effect of positional changes and N2O administration on pain, nausea, and vomiting in pneumoperitoneum with CO2 after laparoscopic cholecystectomy in Shahid Jalil Hospital, Yasuj.

A clinical trial with a randomized controlled design has been conducted, comprising two parallel three-sided groups in Phase 3 involving 126 patients. For randomization, the website kitset.ir is utilized to generate random numbers.

The type of study conducted is a three-blind clinical trial. Patients who are candidates for laparoscopic cholecystectomy surgery are allocated to either intervention or control groups through sequential random allocation. This means that nobody, including researchers and participants, knows which individual is in the intervention group and which is in the control group.

Inclusion criteria: No acute cholecystitis No addiction or substance abuse No allergies to medications No mental or psychological issues No diabetes or other systemic diseases as per ASA score Exclusion criteria: Severe inflammation and adhesions requiring open surgery Gallbladder rupture and bile leakage Excessive bleeding during surgery leading to peritoneal irritation Patient unwillingness to continue participation after surgery

Group 1: This group of patients undergoes the expulsion of CO2 gas from the abdomen and the introduction of N2O gas. Group 2: Patients in this group exclusively utilize Trendelenburg and reverse Trendelenburg maneuvers along with respiratory ventilation for the evacuation of CO2 gas. Group 3: These patients constitute the control group, where only CO2 gas is evacuated from the abdomen after the completion of the procedure.

Pain, nausea, and vomiting

After obtaining ethical approval prior to surgery, all patients will be provided with sufficient information about the study and will be asked to sign a written informed consent form. Subsequently, using randomization through the kitset.ir website to generate random numbers, patients will be allocated into one of three study groups (each group consisting of 42 patients). This study is a double-blind randomized clinical trial designed according to the CONSORT checklist.

Participants: Are unaware of their group allocation. Principal Investigator: Is unaware of the participants' group allocation. Healthcare Staff: Responsible for patient care are unaware of the group allocation. Data Collectors: Are unaware of the group allocation. Outcome Assessors: Are unaware of the group allocation. Data Safety and Monitoring Committee: Is unaware of the group allocation. Manuscript Preparers: Are unaware of the group allocation.

After completing the study and publishing the article, if requested by the journal, the non-identifiable data file can be published.

6 months after publication of the results

Only researchers employed in academic and scientific institutions can use data if permitted by the university.

If granted permission, researchers can utilize the data after conducting meta-analysis and systematic review.

They can email the corresponding author for permission. s.mahdighazanfari@gmail.com

The requester, upon introducing themselves and providing their qualifications, field of work, and the study they are conducting, can request the data by sending an email. A response will be provided to them within a maximum of one week after the email is sent. If 6 months have passed since the results were published, the data will be made available to them.