ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

CO2 pneumoperitoneum

Cerebral oxygen saturation

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Surgery

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]

Early detection / Screening

Intervention code [2]

Prevention

Comparator / control treatment

PEEP 0 (zero) group is the control group.

Control group

Dose comparison

Outcomes

Primary outcome [1]

Cerebral oxygen saturation values as assessed by near infrared spectroscopy

Timepoint [1]

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]

Hemodynamic parameters (HR, MBP) continuously recorded from the anaesthetic machine monitors.

Timepoint [1]

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]

Peak inspiratory pressure (PIP) values continuously recorded from the anaesthetic machine monitors.

Timepoint [2]

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?

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]

Turkey

State/province [1]

Konya

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Konya Training and Research Hospital

Address [1]

Konya Training and Research Hospital, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Meram KONYA,
Postcode:42090

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Necmettin Erbakan University Meram School of Medicine

Ethics committee address [1]

Necmettin Erbakan University Meram School of Medicine, Akyokus, Meram-Konya 42080

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

04/07/2014

Approval date [1]

09/07/2014

Ethics approval number [1]

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

Dr Mehmet SARGIN

Address

Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA

Country

Turkey

Phone

+905322662766

Fax

mehmet21sargin@yahoo.com

Contact person for public queries

Name

Sadik OZMEN

Address

Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA

Country

Turkey

Phone

+903322212250

Fax

sadikozmen@hotmail.com

Contact person for scientific queries

Name

Sadik OZMEN

Address

Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA

Country

Turkey

Phone

+903322212250

Fax

sadikozmen@hotmail.com

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

Source	Title	Year of Publication	DOI
Embase	Comparison of the effects of different positive end-expiratory pressure levels on cerebral oxygen saturation with near infrared spectroscopy during laparoscopic cholecystectomy.	2017	https://dx.doi.org/10.1097/SLE.0000000000000372

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically