NCT04671121

Pneumoperitoneum and Cerebral Oxygenation

Completed NA Last updated 19 December 2020

What this trial tests

NA trial testing Standart pressure pneumoperitoneum in Laparoscopic Nephrectomy in 62 participants. Completed in 1 November 2020.

Timeline

1 January 2020

Primary endpoint
1 November 2020

1 November 2020

Quick facts

Lead sponsor	Ondokuz Mayıs University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	62
Start date	1 January 2020
Primary completion	1 November 2020
Estimated completion	1 November 2020
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Standart pressure pneumoperitoneum
• Low pressure pneumoperitoneum

Conditions studied

• Laparoscopic Nephrectomy — all drugs for Laparoscopic Nephrectomy →
• Cerebral Oxygen Saturation — all drugs for Cerebral Oxygen Saturation →

Sponsor

Ondokuz Mayıs University

Who can join

Adults 18 to 65, any sex, with Laparoscopic Nephrectomy or Cerebral Oxygen Saturation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, the changes in cerebral oxygen saturation due to low and high pressure pneumoperitoneum implementation were measured in patients who underwent laparoscopic nephrectomy. This prospective, double-blind study included 62 American Society of Anesthesiologists (ASA) PS class I-III patients aged 18-65 years who underwent laparoscopic nephrectomy (simple, partial, or radical). Patients were randomly classified into 2 groups: Group LP (n = 31) included patients who were treated with low pressure pneumoperitoneum (8 mmHg) and Group SP (n = 31) included patients who were treated with standard pressure (14 mmHg). A standard anesthesia protocol was used in both groups. Bilateral rSO2 values were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient went to the recovery unit. Data for mean arterial pressure (MAP), peak heart rate (HR), peripheral oxgen saturation (SpO2), and end-tidal carbon dioxide (ETCO2) were also recorded at the same time intervals. Arterial blood gas was analyzed in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position. Patient demographic data, duration of anesthesia, duration of surgery, lateral position time, pneumoperitoneum time, and recovery time were also recorded. used in both groups. Bilateral rSO2 values were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient went to the recovery unit. Data for mean arterial pressure (MAP), peak heart rate (HR), SpO2, and ETCO2 were also recorded at the same time intervals. Arterial blood gas was analyzed in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position. Patient demographic data, duration of anesthesia, duration of surgery, lateral position time, pneumoperitoneum time, and recovery time were also recorded.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.