The effects of positive end-expiratory pressure at different levels on postoperative respiration parameters in patients undergoing laparoscopic cholecystectomy

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001191684
• Date of registration: 12/11/2014
• Prospective Registration: No
• Primary sponsor: Mehmet Aksoy
• Public title: The effects of positive end-expiratory pressure at different levels on postoperative respiration parameters in patients undergoing laparoscopic cholecystectomy
• Scientific title: The effects of positive end-expiratory pressure at different levels (0, 5 and 8 cmH2O) on postoperative respiration parameters in patients undergoing laparoscopic cholecystectomy
• Date of first enrolment: 10/06/2013
• Target sample size: 84
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001191684.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3

Countries of recruitment

Turkey

Contacts

• Name: Dr Mehmet Aksoy

• Name: Dr Ilker Ince

Key inclusion & exclusion criteria

Inclusion criteria: 105 consecutive patients, with American Society of Anesthesiologists (ASA) physical status I or II, aged 18-65 years undergoing elective laparoscopic cholecystectomy were included in this study
Exclusion criteria: Patients with ASA III-V physical status, smoking, body mass indexes (BMI) > 40 kg/m2, cardiorespiratory disease and unable to perform pulmonary function tests were excluded from the study

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Surgery - Other surgery

Respiratory - Normal development and function of the respiratory system

Anaesthesiology - Other anaesthesiology

postoperative respiration parameters following cholecystectomy;
postoperative respiration parameters following cholecystectomy

Intervention(s)

From June 2013 to March 2014, 105 consecutive patients undergoing elective laparoscopic cholecystectomy were included in this study. Preoperatively, physical examination of the patients was performed by an anaesthesiologist and all patients received detailed information about the respiratory function test and spirometry. Before the operation, respiratory function was evaluated using spirometry (Vitalograph micro. 63000 Series, Ennis, Ireland) by an anaesthesiologist blinded to the group assignment. Before entering the operating room, all patients received 500 mL of colloids via intravenous (IV) cannula and premedication was provided with intramuscular (im) 0.1 mg/kg midazolam for all patients before induction of anaesthesia. Standard monitoring including non-invasive arterial pressure, electrocardiography and pulse oximetry was established in the operating room. Before the operation, heart rate (HR), peripheral oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) values were recorded. Patients were randomly allocated into one of the three groups after induction of general anaesthesia using a computer generated random number table. Group I (n=35) did not receive PEEP whereas group II (n=35) received PEEP as 5 cmH2O and group III received PEEP as 8 cm H2O in mechanical ventilation during laparoscopic procedure . Same anaesthesia protocol was applied for all patients. Anaesthesia induction was provided with IV 2. microg/kg fentanyl, IV 2mg/kg propofol and 0.5-1 mg/kg rocuronium. All patients received colloids at a rate of 3-5 ml/kg/h during operation. Tracheal intubation was performed and anaesthesia was maintained with sevoflurane 1-2%, air (50%), oxygen (50%) and remifentanyl infusion at a rate of 0.15-0.25

Primary Outcome(s)

to evaluate postoperative respiration parameters including forced expiratory volume (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF) using spirometer in patients undergoing laparoscopic cholecystectomy following the 0, 5 and 8 cmH2O PEEP applications. [Timepoint:1 hour before the operation (T1) and, 1 (T2), 6 (T3) and 24 hours (T4) after extubation]

Secondary Outcome(s)

to evaluate mean arterial pressure (MAP) values using standard monitorization in patients undergoing laparoscopic cholecystectomy following the 0, 5 and 8 cmH2O PEEP applications. [1 hour before the operation (T1) and, 1 (T2), 6 (T3) and 24 hours (T4) after extubation]

to evaluate peripheral oxygen saturation (SpO2) changes using pulse oximetry in patients undergoing laparoscopic cholecystectomy following the 0, 5 and 8 cmH2O PEEP applications.[1 hour before the operation (T1) and, 1 (T2), 6 (T3) and 24 hours (T4) after extubation]

to evaluate postoperative heart rate (HR) changes using electrocardiography in patients undergoing laparoscopic cholecystectomy following the 0, 5 and 8 cmH2O PEEP applications. [1 hour before the operation (T1) and, 1 (T2), 6 (T3) and 24 hours (T4) after extubation]

Secondary ID(s)

None

Source(s) of Monetary Support

Dr. Mehmet AKSOY

Secondary Sponsor(s)

Bahadir Ciftci

Ilker Ince

Ethics review

Status: Approved
Approval date:
Contact:

Ataturk University Medical Faculty Ethical Committee, Erzurum,Turkey