None listed
Conditions
Brief summary
Surgical removal of the adrenal glands is in our unit performed by a posterior approach were the adrenal is accessed from the back with keyhole surgery. The retroperitoneum (space around the adrenal) is inflated with pressurized carbon dioxide (CO2) to create an operative space. Normally, we use a starting pressure of 25mmHg, which may be increased to 28 mmHg, at the surgeon’s discretion. Occasionally, CO2 retention with increasing levels of CO2 in blood can occur and the retroperitoneum needs to be deflated for the patients CO2 levels to recover. On the other hand, with too low pressure, bleeding may increase and visibility may become be impaired. In the early experiences of retroscopicadrenalectomy, centers reported that they used pressures of 12mmHg to 15mmHg with success. However, many authors claim to have less bleeding and better visibility using pressures over 20-24mmHg. Also, in the largest cohort of retroperitoneoscopic adrenalectomy published, a pressure between 20mmHg and 28mmHg was routinely used without any excess of adverse events. The implications of using different pressures have been reported in a few studies. The first one compared pressures at 15 mmHg and at 20mmHg in retroperitoneoscopic adrenalectomy and showed a statistical, but not clinical, significant difference in arterial pCO2 levels. Another study did not show any difference in arterial carbon dioxide pressure between patients undergoing open and retroperitoneoscopic adrenalectomy at 12 to 16mmHg. There are no studies examining the different physiological effects of pressures between 25-20mmHg in retroperitoneoscopic adrenalectomy, but nonetheless high pressures are routinely used in general practise with very few adverse events. The current study proposes to start with a pressure of 25 mmHg in group A and 20 mmHg in Group B as insufflation pressures during retroperitonescopic (keyhole) adrenalectomy. Routine clinical blood samples (arterial line blood gases) will be drawn every 30 minutes, and these samples are, together with selected clinical data, recorded for data analysis.
Interventions
Study Procedures:
All patients will undergo retro-peritoneoscopic adrenalectomy. A opening into the retroperitoneal space will be created below the tip of the 12 th rib. A 12 mm balloon port will be placed into the retroperitoneal space after which carbon dioxide will be administered into the retroperitoneal space. The carbon dioxide will be administered throughout the procedure. The current study proposes to administer a pressure of 25 mmHg in group A and 20 mmHg in Group B.
If the surgeon bel
Study Procedures: All patients will undergo retro-peritoneoscopic adrenalectomy. A opening into the retroperitoneal space will be created below the tip of the 12 th rib. A 12 mm balloon port will be placed into the retroperitoneal space after which carbon dioxide will be administered into the retroperitoneal space. The carbon dioxide will be administered throughout the procedure. The current study proposes to administer a pressure of 25 mmHg in group A and 20 mmHg in Group B. If the surgeon believes there is impaired visibility or bleeding in group B, the CO2 pressure is increased to 25 mmHg. If the patient experiences CO2 retention, the operation will be halted, and then restarted at the pressured used, in line with current clinical routine. Routine clinical blood samples (arterial line blood gases) will be taken every thirty minutes according to the clinical routine. The results of these blood samples are recorded for data analysis. Also, clinical data such as blood pressure, central venous pressure, respiratory minute volume, Tidal volume, and End tidal carbon dioxide level will be collected every thirty minutes. Other clinical data such as patient age, gender, tumor size, pathology of tumor, and operative time are also recorded.
Sponsors
Dr Mark Sywak
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All adult patients undergoing retroperitoneoscopic adrenalectomy at north shore private by Dr Mark Sywak.
Exclusion criteria
Pregnancy. Mental impairment
Outcome results
None listed