Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000581561
Ethics application status
Approved
Date submitted
16/05/2015
Date registered
3/06/2015
Date last updated
6/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effects of different PEEP (positive end-expiratory pressure) levels on cerebral oxygen saturation in patients undergoing laparoscopic cholecystectomy
Scientific title
Comparison of the effects of different PEEP levels on cerebral oxygen saturation with near infrared spectroscopy during laparoscopic cholecystectomy
Secondary ID [1] 286724 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CO2 pneumoperitoneum 295087 0
Cerebral oxygen saturation 295200 0
Condition category
Condition code
Anaesthesiology 295337 295337 0 0
Other anaesthesiology
Surgery 295450 295450 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred and five patients between the ages of 18-60 yr, ASA physical status I and II, scheduled to undergo routine laparoscopic cholecystectomy under general anesthesia, were studied. The patients were randomized, by using a computer-generated block randomisation, into 3 groups: Group I (n=35) with no external PEEP, Group II (n=35) with external PEEP of 5 cmH2O, Group III (n=35) with external PEEP of 10 cmH2O. Routine monitors (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff ) and BIS monitoring were applied. In addition to this monitoring cerebral oximeter sensors were attached to frontotemporal areas (both right and left). Fasting periods were in accordance with ASA guidelines, and no one premedicated. Anesthesia was induced with propofol (2 mg/kg) and fentanyl (1-2 microg/kg), and endotracheal intubation was facilitated using rocuronium. After induction, volume- controlled mechanical ventilation (tidal volume adjusted to 8 mL/kg with no application of PEEP in Group I, 5 cmH2O in Group II, 10 cmH2O in Group III and respiratory rates were adjusted to achieve an end-tidal carbon dioxide of 30 to 35 mmHg) was initiated. All patients were ventilated with the same anesthetic machine. Anaesthesia was maintained using sevoflurane 1–2% in an oxygen / air mixture and remifentanil (0,25 microg/kg/min) accompanied by BIS monitoring. The CO2 pneumoperitoneum (PP) was introduced with a closed Veress needle technique, and the intraa-bdominal insufflation pressure was limited to 10-12 mmHg. After introduction of the four trocars and insufflation of CO2, the patient was placed in the reverse Trendelenburg position, using up to 30 degree of head-up tilt. HR, MBP, oxygen saturation (SpO2) and rSO2 values were continuously recorded from awake status to tracheal extubation (basal, after induction, after intubation, immediately after pneumoperitoneum, every 5 minutes during pneumoperitoneum, immediately after desufflation of CO2, at the end of surgery, after). ETCO2, peak inspiratory pressure (PIP) (after intubation, immediately after pneumoperitoneum, every 5 minutes during pneumoperitoneum, immediately after desufflation of CO2, at the end of surgery, after), operation time, PP time and intraoperative fluid administration were also recorded.
Intervention code [1] 291883 0
Early detection / Screening
Intervention code [2] 291884 0
Prevention
Comparator / control treatment
PEEP 0 (zero) group is the control group.
Control group
Dose comparison

Outcomes
Primary outcome [1] 295087 0
Cerebral oxygen saturation values as assessed by near infrared spectroscopy
Timepoint [1] 295087 0
Cerebral oxygen saturation values were continuously recorded from awake status to tracheal extubation
(basal, after induction, after intubation, immediately after pneumoperitoneum, every 5 minutes during pneumoperitoneum, immediately after desufflation of CO2, at the end of surgery, after).
Secondary outcome [1] 314742 0
Hemodynamic parameters (HR, MBP) continuously recorded from the anaesthetic machine monitors.
Timepoint [1] 314742 0
Hemodynamic parameters (HR, MBP) were continuously recorded from awake status to tracheal extubation (basal, after induction, after intubation, immediately after pneumoperitoneum, every 5 minutes during pneumoperitoneum, immediately after desufflation of CO2, at the end of surgery, after).
Secondary outcome [2] 314743 0
Peak inspiratory pressure (PIP) values continuously recorded from the anaesthetic machine monitors.
Timepoint [2] 314743 0
Peak inspiratory pressure (PIP) were recorded (after intubation, immediately after pneumoperitoneum, every 5 minutes during pneumoperitoneum, immediately after desufflation of CO2, at the end of surgery, after).

Eligibility
Key inclusion criteria
Scheduled for elective laparoscopic cholecystectomy.

ASA physical status I and II.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with morbid obessity (body mass index > 30 kg/m2), Patients with cerebrovascular disease,
Patients with respiratory disease,
Patients with cardiovascular disease,
Patients with metabolic disease
patients with acute cholecystitis.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2015
Actual
1/07/2015
Date of last participant enrolment
Anticipated
1/02/2016
Actual
1/02/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 6883 0
Turkey
State/province [1] 6883 0
Konya

Funding & Sponsors
Funding source category [1] 291283 0
Hospital
Name [1] 291283 0
Konya Training and Research Hospital
Country [1] 291283 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Konya Training and Research Hospital, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Meram KONYA,
Postcode:42090
Country
Turkey
Secondary sponsor category [1] 289958 0
None
Name [1] 289958 0
Address [1] 289958 0
Country [1] 289958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292849 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 292849 0
Necmettin Erbakan University Meram School of Medicine, Akyokus, Meram-Konya 42080
Ethics committee country [1] 292849 0
Turkey
Date submitted for ethics approval [1] 292849 0
04/07/2014
Approval date [1] 292849 0
09/07/2014
Ethics approval number [1] 292849 0
2014/97

Summary
Brief summary
Laparoscopic surgeries have increased in frequency as replacements for a variety of surgical procedures. However, they require pneumoperitoneum, which raises concerns about the adverse effects on respiratory mechanics. It is demonstrated that application of positive end-expiratory pressure improved respiratory mechanics during pneumoperitoneum. Carbon dioxide (CO2) pneumoperitoneum also affects cerebral hemodynamics. We aimed to investigate changes in rSO2, as assessed by nearinfrared spectroscopy, associated with different PEEP levels during laparoscopic cholecystectomy.
Trial website
Trial related presentations / publications
Trial is in evaluation process.
Public notes

Contacts
Principal investigator
Name 57318 0
Dr Mehmet SARGIN
Address 57318 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 57318 0
Turkey
Phone 57318 0
+905322662766
Fax 57318 0
Email 57318 0
[email protected]
Contact person for public queries
Name 57319 0
Sadik OZMEN
Address 57319 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 57319 0
Turkey
Phone 57319 0
+903322212250
Fax 57319 0
Email 57319 0
[email protected]
Contact person for scientific queries
Name 57320 0
Sadik OZMEN
Address 57320 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 57320 0
Turkey
Phone 57320 0
+903322212250
Fax 57320 0
Email 57320 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparison of the effects of different positive end-expiratory pressure levels on cerebral oxygen saturation with near infrared spectroscopy during laparoscopic cholecystectomy.2017https://dx.doi.org/10.1097/SLE.0000000000000372
N.B. These documents automatically identified may not have been verified by the study sponsor.