Effect of different levels of positive end-expiratory pressure (PEEP) on respiratory status during gynecologic laparoscopy

1. Comparison of pH alteration during gynecologic laparoscopy between study groups. 2. Comparison of HCO3 alteration during gynecologic laparoscopy between study groups. 3. Comparison of PCO2 alteration during gynecologic laparoscopy between study groups. 4. Comparison of Base excess (BE) alteration during gynecologic laparoscopy between study groups. 5. Comparison of PO2 alteration during gynecologic laparoscopy between study groups. 6. Comparison of O2 saturation (Sat PO2) alteration during gynecologic laparoscopy between study groups. 7. Comparison of ET CO2 alteration during gynecologic laparoscopy between study groups.

In current double-blinded randomized clinical trial, 36 women candidate to undergo laparoscopic gynecological surgery, aged between 18 and 60 years old with ASA class I physical status will be enrolled. Patients will be randomly assigned to study groups, considering positive end-expiratory pressure (PEEP) rate: ZEEP group will undergo routine PPV without PEEP administration, PEEP5 group will receive PEEP: 5cm H2O in addition to routine PPV and PEEP10 group will receive PEEP: 10cm H2O in addition to routine PPV and a code will be allocated to each of participants.

Current investigation will be performed in Obstetrics and Gynecology center in Tabriz. In present study, patients, investigator, care provider, outcome assessor and data analyzer are blinded to participants study groups. The anesthesiologist will be responsible for data collection and outcome assessing, will not be aware of interventions and study group.

In current double-blinded randomized clinical trial, 36 women candidate to undergo laparoscopic gynecological surgery, aged between 18 and 60 years old with ASA class I physical status will be enrolled and patient with systemic and psychotic disorders will be excluded.

Maintenance of general anesthesia will be done via midazolam, remifentanil, propofol and atracurium. Positive pressure ventilation (PPV) with volume controlled ventilation (VCV) will be applied as follows, tidal volume of 8-10 ml per minute, respiratory rate of 12 per minute and 1 to 2 rate of inhalation and exhalation. Patients will be randomly assigned to study groups, considering positive end-expiratory pressure (PEEP) rate: ZEEP group will undergo routine PPV without PEEP administration, PEEP5 group will receive PEEP: 5cm H2O in addition to routine PPV and PEEP10 group will receive PEEP: 10cm H2O in addition to routine PPV and a code will be allocated to each of participants.

Hemodynamic variables including heart rate, systolic and diastolic blood pressure, mean arterial pressure and arterial oxygen saturation will be measured before induction of anesthesia, immediately after induction, at 5th,10th, 20th, 30th, 60th minutes and at the end of operation. In addition, surgery duration, anesthesia duration, duration of pneumoperitoneum, administered intravenous fluid volume, volume of blood loss, urine output and dysrhythmia incidence with regard to its type, will be recorded.

Stratified block randomization method used to randomly allocation of patients to study groups.

In present study, patients, investigator, care provider, outcome assessor and data analyzer are blinded to participants study groups. The study team includes an anesthesiologists, who is responsible for data collection and outcome assessing, who is not in charge of anesthesia management, thus is not aware of interventions and study group. In addition, all study groups and subsequent interventions will be introduced to the patients and it will been mentioned in the written consent that patients will be blinded to the study groups and interventions.

All collected deidentified IPD will be shared.

Th data will be available for 1 year, starting 3 months after publication.

The data will be available only for academic institutions.

Not decided.

atashkhoii@tbzmed.ac.ir

In order to acquire study data, the applicants should send an email containing their purpose and sufficient information about their work.