Intracranial Pressure IncreaseNCT05668208
Do Extraperitoneal Laparoscopic Surgeries Increase Intracranial Pressure?
A study testing E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea) in people with Intracranial Pressure Increase, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
When the literature is examined, it has been reported in many studies that intracranial pressure increases due to laparoscopic procedures performed in the intraperitoneal area. The mechanism of increased intracranial pressure (ICP) associated with insufflation is most likely due to impaired venous drainage of the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intracranial Pressure Increase
- What is being tested?
- E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2023to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old,
- ASA (American Society of Anesthesiologists) I-II,
- patients who will undergo laparoscopic cholecystectomy with the diagnosis of symptomatic cholelithiasis or TEP due to inguinal hernia.
Who cannot join
- patients who were switched to open surgery,
- glaucoma, corneal disease, eye surgery,
- cerebrovascular disease,
- any neurological disease,
- chronic kidney disease,
- liver cirrhosis,
- patients whose peritoneum was opened during TEP.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Science Konya City Hospital
Konya
About this study
Official title: Comparison of the Effects of Extraperitoneal and Transperitoneal Laparoscopic Surgeries on Intracranial Pressure: A Prospective Clinical Study
When the literature is examined, it has been reported in many studies that intracranial pressure increases due to laparoscopic procedures performed in the intraperitoneal area. The mechanism of increased intracranial pressure (ICP) associated with insufflation is most likely due to impaired venous drainage of the lumbar venous plexus at increased intra-abdominal pressure. Changes in ICP can be monitored by ultrasonographic measurement of optic nerve sheath diameter (ONSD), which is a generally accepted simple, reliable and non-invasive ICP measurement technique. In meta-analyses conducted on this subject, it has been revealed that ICP elevation during laparoscopy can be observed with a significant increase in ONSD in the early (0 30 minutes) and late (30-120 minutes) periods during carbondioxid (CO2) pneumoperitoneum.
However, the effect of laparoscopic procedures performed in the extraperitoneal area on the central nervous system is not clear. There is not found any study in the literature comparing laparoscopic procedures, especially performed extraperitoneally and transperitoneally, and their effects on intracranial pressure.
The aim of the study compare to laparoscopic cholecystectomy performed in the transperitoneal area and (totally extra-peritoneal) TEP inguinal hernia repair performed in the extraperitoneal area in terms of intracranial pressure relationship.
Read the detailed description
A total of 60 patients, including 30 patients who underwent laparoscopic cholecystectomy and 30 patients who underwent TEP inguinal hernia repair between December 2022 and January 2023, were included in the study.
Inclusion criteria: 18-70 years old, ASA (American Society of Anesthesiologists) I-II, patients who will undergo laparoscopic cholecystectomy with the diagnosis of symptomatic cholelithiasis or TEP due to inguinal hernia.
Exclusion criteria: patients who were switched to open surgery, glaucoma, corneal disease, eye surgery, cerebrovascular disease, any neurological disease, chronic kidney disease, liver cirrhosis, and patients whose peritoneum was opened during TEP.
Anesthesia
All patients will undergo general anesthesia and will be given Propofol 2 mg/kg and Fentanyl 2 μg/kg intravenously (IV) for analgesia. Endotracheal intubation will be performed after a 4-minute injection of 0.1 mg/kg Vecuronium. Anesthesia will be maintained with an oxygen-air ratio of 50:50 propofol. For postoperative nausea and vomiting prophylaxis, 4 mg of dexamethasone will be given at induction. Intermittent doses of Fentanyl and Vecuronium will be given from time to time as needed. At the end of the surgery, the neuromuscular paralysis will be reversed with 0.05 mg/kg Neostigmine and 0.02 mg/kg Glycopyrrolate Injection, and the patient will be extubated.
Surgical Method in Patients Undergoing Laparoscopic Cholecystectomy:
With a mini incision made under the umbilicus, the abdomen will be entered with a 10 mm trocar. Pneumoperitoneum will be created with CO2 gas. The intra-abdominal pressure will be set to 14 mmHg. Under the guidance of the laparoscope, 1 10 mm trocar from the subxiphoid region and 2 more 5 mm trocars from the subcostal region will be inserted. The cystic artery and cystic duct will be clipped and cut, exposing the Callot's triangle. The gallbladder will then be separated from the liver bed and removed through the abdomen. The CO2 in the abdomen will be evacuated and the trocars will be removed. The operation will be terminated by closing the fascia defect and the skin.
Surgical Method in Patients with Totally Extra-peritoneal (TEP) Repair:
The outer sheath of the rectus muscle will be seen by passing through the skin and subcutaneous tissue with a mini incision made from the umbilicus. A 10 mm trocar will be placed in the preperitoneal space and CO2 insufflation will be applied. The pressure will be set to 14 mmHg. Two more 5 mm trocars will be placed between the umbilicus and the sympisis pubis under the laparoscope. The preperitoneal inguinal region will be dissected with a laparoscopic dissector and holder. The hernial sac will be released. A 10x15 cm prolene mesh will be fixed to cover the femoral, direct and indirect hernia areas. The trocars will be removed by evacuating the CO2 gas. The skin will be closed and the operation will be terminated.
Results
The primary outcome of the study is the comparison of ONSD measurements between patients who underwent laparoscopic cholecystectomy and TEP repair.
Secondary outcomes are age, gender, ASA score, height, weight, comorbidities, heart rate, blood pressure, oxygen saturation (SpO2), end tidal CO2 (ETCO2) measurements.
ONSD measurement:
ONSD will be performed with transorbital sonography by 2 investigators unaware of the study protocol. Transorbital sonography will be performed using an E-CUBE i7 ultrasound system (mechanical index, 0.2; thermal index, 0) using a linear 6-13 Hz probe (Alpinion Medical Systems, Seoul, Republic of Korea). To prevent eye damage, a sterile occlusion gel will be used and gently probed without applying pressure to the eyelid. Ultrasonographic images of the area will be obtained at the optic nerve level and the ONSD image will be taken 3 mm behind the optic nerve head. The optic nerve sheath will be taken from both eyes at certain times, preoperatively (T0), at the end of insufflation (T1), and at the end of the operation (T2). The average value of the 3 measurements will be recorded as ONSD. Heart rate (HR), blood pressure, SPO2 and EtCO2 will be recorded separately at each time point.
Statistical analysis The primary aim of this study is to compare the effect of laparoscopic surgeries performed in the preperitoneal and intraperitoneal areas on OSD. For clinically reliable results, at least 30 subjects in each group had to detect a difference of 0.3 mm in ONSD measurements. Sample size was calculated based on a pilot study. Multivariate observational analyzes of all data will be performed. Descriptive statistics will be given for hidden variables. Mean and standard deviation will be given for continuous variables, frequency and percentage will be given for categorical variables. Mixed effects models will be created for constant variables. Group, time and group-time interaction will be evaluated. The t-test will be used to measure continuous variables between the 2 groups. When group-time interaction is important, least squares means will be compared. Statistical Analysis SAS (University Edition 9.4) software will be used for data analysis. A P value of <0.05 will be considered significant.
- Conditions
- Intracranial Pressure Increase
- Being tested
- E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea)
- Keywords
- intracranial pressure, laparoscopic, transperitoneally, extraperitoneal
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea)Device
ONSD measurement will be made using the E-CUBE i7 ultrasound system.
| Study group | Role | What they receive |
|---|---|---|
| extraperitoneal surgery group - TEP inguinal hernia repair | Experimental | The external sheath of the rectus muscle was seen by passing through the skin and subcutaneous tissue with a mini incision made from the umbilicus edge. A 10 mm trocar was placed in the preperitoneal area and CO2 insufflation was performed. The pressure was set to 14 mmHg. Two more 5 mm trocars were inserted between the umbilicus and the sympisis pubis under the laparoscope. The preperitoneal inguinal area was dissected with a laparoscopic dissector and grasper. The hernia sac was released. A 10x15 cm prolene mesh was spread and fixed to cover the femoral, direct and indirect hernia areas. The trocars were removed by evacuating the CO2 gas. The skin was closed and the operation was terminated. Receives: Device: E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea) |
| transperitoneal surgery group - laparoscopic cholecystectomy | Active comparator | With a mini incision made under the umbilicus, the abdomen was entered with a 10 mm trocar. Pneumoperitoneum was created with CO2 gas. Intra-abdominal pressure was set to 14 mmHg. Under the guidance of the laparoscope, one 10 mm trocar from the subxiphoid area and two more 5 mm trocars from the subcostal area were inserted. The cystic artery and cystic duct were clipped and cut by exposing the Callot triangle. Then the gallbladder was separated from the liver bed and taken out of the abdomen. The CO2 in the abdomen was evacuated and the trocars were removed. The fascia defect and skin were closed and the operation was terminated. Receives: Device: E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurements of optic nerve sheath diameter (ONSD)
mm
Measured: during surgery
Secondary outcomes (4)
heart rate value
/min
Measured: during surgery
blood pressure
mmHg
Measured: during surgery
SPO2 measurements
Measured: during surgery
ETCO2 measurements
mmHg
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start6 Jan 2023
- Primary completion15 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Eşref Ulutaş, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668208
- Sponsor's protocol ID
- 22222222
- Status last verified
- Mar 2023
- First submitted
- 11 Dec 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steiner CA, Karaca Z, Moore BJ, Imshaug MC, Pickens G. Surgeries in Hospital-Based Ambulatory Surgery and Hospital Inpatient Settings, 2014. 2017 May [updated 2020 Jul 20]. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #223. Available from http://www.ncbi.nlm.nih.gov/books/NBK442035/
PubMed 28722845Montorfano L, Giambartolomei G, Funes DR, Lo Menzo E, Dip F, White KP, Rosenthal RJ. The Cushing reflex and the vasopressin-mediated hemodynamic response to increased intracranial pressure during acute elevations in intraabdominal pressure. Surgery. 2020 Feb;167(2):478-483. doi: 10.1016/j.surg.2019.10.006. Epub 2019 Dec 6.
PubMed 31813477Rosenthal RJ, Friedman RL, Chidambaram A, Khan AM, Martz J, Shi Q, Nussbaum M. Effects of hyperventilation and hypoventilation on PaCO2 and intracranial pressure during acute elevations of intraabdominal pressure with CO2 pneumoperitoneum: large animal observations. J Am Coll Surg. 1998 Jul;187(1):32-8. doi: 10.1016/s1072-7515(98)00126-4.
PubMed 9660022Yashwashi T, Kaman L, Kajal K, Dahiya D, Gupta A, Meena SC, Singh K, Reddy A. Effects of low- and high-pressure carbon dioxide pneumoperitoneum on intracranial pressure during laparoscopic cholecystectomy. Surg Endosc. 2020 Oct;34(10):4369-4373. doi: 10.1007/s00464-019-07207-w. Epub 2019 Oct 15.
PubMed 31617096Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.
PubMed 27956677Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18.
PubMed 20167583Citerio G, Vascotto E, Villa F, Celotti S, Pesenti A. Induced abdominal compartment syndrome increases intracranial pressure in neurotrauma patients: a prospective study. Crit Care Med. 2001 Jul;29(7):1466-71. doi: 10.1097/00003246-200107000-00027.
PubMed 11445709Rosenthal RJ, Hiatt JR, Phillips EH, Hewitt W, Demetriou AA, Grode M. Intracranial pressure. Effects of pneumoperitoneum in a large-animal model. Surg Endosc. 1997 Apr;11(4):376-80. doi: 10.1007/s004649900367.
PubMed 9094281Dip F, Nguyen D, Rosales A, Sasson M, Lo Menzo E, Szomstein S, Rosenthal R. Impact of controlled intraabdominal pressure on the optic nerve sheath diameter during laparoscopic procedures. Surg Endosc. 2016 Jan;30(1):44-9. doi: 10.1007/s00464-015-4159-0. Epub 2015 Apr 22.
PubMed 25899811
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Extraperitoneal and Transperitoneal Laparoscopic Surgeries on Intracranial Pressure: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05668208
- Acronym / sponsor ID
- 22222222
- Conditions
- Intracranial Pressure Increase
- Keywords
- intracranial pressure, laparoscopic, transperitoneally, extraperitoneal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When the literature is examined, it has been reported in many studies that intracranial pressure increases due to laparoscopic procedures performed in the intraperitoneal area. The mechanism of increased intracranial pressure (ICP) associated with insufflation is most likely due to impaired venous drainage of the lumbar venous plexus at increased intra-abdominal pressure. Changes in ICP can be monitored by ultrasonographic measurement of optic nerve sheath diameter (ONSD), which is a generally accepted simple, reliable and non-invasive ICP measurement technique. In meta-analyses conducted on this subject, it has been revealed that ICP elevation during laparoscopy can be observed with a significant increase in ONSD in the early (0 30 minutes) and late (30-120 minutes) periods during carbondioxid (CO2) pneumoperitoneum.
However, the effect of laparoscopic procedures performed in the extraperitoneal area on the central nervous system is not clear. There is not found any study in the literature comparing laparoscopic procedures, especially performed extraperitoneally and transperitoneally, and their effects on intracranial pressure.
The aim of the study compare to laparoscopic cholecystectomy performed in the transperitoneal area and (totally extra-peritoneal) TEP inguinal hernia repair performed in the extraperitoneal area in terms of intracranial pressure relationship.
Detailed description
A total of 60 patients, including 30 patients who underwent laparoscopic cholecystectomy and 30 patients who underwent TEP inguinal hernia repair between December 2022 and January 2023, were included in the study.
Inclusion criteria: 18-70 years old, ASA (American Society of Anesthesiologists) I-II, patients who will undergo laparoscopic cholecystectomy with the diagnosis of symptomatic cholelithiasis or TEP due to inguinal hernia.
Exclusion criteria: patients who were switched to open surgery, glaucoma, corneal disease, eye surgery, cerebrovascular disease, any neurological disease, chronic kidney disease, liver cirrhosis, and patients whose peritoneum was opened during TEP.
Anesthesia
All patients will undergo general anesthesia and will be given Propofol 2 mg/kg and Fentanyl 2 μg/kg intravenously (IV) for analgesia. Endotracheal intubation will be performed after a 4-minute injection of 0.1 mg/kg Vecuronium. Anesthesia will be maintained with an oxygen-air ratio of 50:50 propofol. For postoperative nausea and vomiting prophylaxis, 4 mg of dexamethasone will be given at induction. Intermittent doses of Fentanyl and Vecuronium will be given from time to time as needed. At the end of the surgery, the neuromuscular paralysis will be reversed with 0.05 mg/kg Neostigmine and 0.02 mg/kg Glycopyrrolate Injection, and the patient will be extubated.
Surgical Method in Patients Undergoing Laparoscopic Cholecystectomy:
With a mini incision made under the umbilicus, the abdomen will be entered with a 10 mm trocar. Pneumoperitoneum will be created with CO2 gas. The intra-abdominal pressure will be set to 14 mmHg. Under the guidance of the laparoscope, 1 10 mm trocar from the subxiphoid region and 2 more 5 mm trocars from the subcostal region will be inserted. The cystic artery and cystic duct will be clipped and cut, exposing the Callot's triangle. The gallbladder will then be separated from the liver bed and removed through the abdomen. The CO2 in the abdomen will be evacuated and the trocars will be removed. The operation will be terminated by closing the fascia defect and the skin.
Surgical Method in Patients with Totally Extra-peritoneal (TEP) Repair:
The outer sheath of the rectus muscle will be seen by passing through the skin and subcutaneous tissue with a mini incision made from the umbilicus. A 10 mm trocar will be placed in the preperitoneal space and CO2 insufflation will be applied. The pressure will be set to 14 mmHg. Two more 5 mm trocars will be placed between the umbilicus and the sympisis pubis under the laparoscope. The preperitoneal inguinal region will be dissected with a laparoscopic dissector and holder. The hernial sac will be released. A 10x15 cm prolene mesh will be fixed to cover the femoral, direct and indirect hernia areas. The trocars will be removed by evacuating the CO2 gas. The skin will be closed and the operation will be terminated.
Results
The primary outcome of the study is the comparison of ONSD measurements between patients who underwent laparoscopic cholecystectomy and TEP repair.
Secondary outcomes are age, gender, ASA score, height, weight, comorbidities, heart rate, blood pressure, oxygen saturation (SpO2), end tidal CO2 (ETCO2) measurements.
ONSD measurement:
ONSD will be performed with transorbital sonography by 2 investigators unaware of the study protocol. Transorbital sonography will be performed using an E-CUBE i7 ultrasound system (mechanical index, 0.2; thermal index, 0) using a linear 6-13 Hz probe (Alpinion Medical Systems, Seoul, Republic of Korea). To prevent eye damage, a sterile occlusion gel will be used and gently probed without applying pressure to the eyelid. Ultrasonographic images of the area will be obtained at the optic nerve level and the ONSD image will be taken 3 mm behind the optic nerve head. The optic nerve sheath will be taken from both eyes at certain times, preoperatively (T0), at the end of insufflation (T1), and at the end of the operation (T2). The average value of the 3 measurements will be recorded as ONSD. Heart rate (HR), blood pressure, SPO2 and EtCO2 will be recorded separately at each time point.
Statistical analysis The primary aim of this study is to compare the effect of laparoscopic surgeries performed in the preperitoneal and intraperitoneal areas on OSD. For clinically reliable results, at least 30 subjects in each group had to detect a difference of 0.3 mm in ONSD measurements. Sample size was calculated based on a pilot study. Multivariate observational analyzes of all data will be performed. Descriptive statistics will be given for hidden variables. Mean and standard deviation will be given for continuous variables, frequency and percentage will be given for categorical variables. Mixed effects models will be created for constant variables. Group, time and group-time interaction will be evaluated. The t-test will be used to measure continuous variables between the 2 groups. When group-time interaction is important, least squares means will be compared. Statistical Analysis SAS (University Edition 9.4) software will be used for data analysis. A P value of <0.05 will be considered significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extraperitoneal surgery group - TEP inguinal hernia repair | Experimental | Device: E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea)The external sheath of the rectus muscle was seen by passing through the skin and subcutaneous tissue with a mini incision made from the umbilicus edge. A 10 mm trocar was placed in the preperitoneal area and CO2 insufflation was performed. The pressure was set to 14 mmHg. Two more 5 mm trocars were inserted between the umbilicus and the sympisis pubis under the laparoscope. The preperitoneal inguinal area was dissected with a laparoscopic dissector and grasper. The hernia sac was released. A 10x15 cm prolene mesh was spread and fixed to cover the femoral, direct and indirect hernia areas. The trocars were removed by evacuating the CO2 gas. The skin was closed and the operation was terminated. |
| transperitoneal surgery group - laparoscopic cholecystectomy | Active comparator | Device: E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea)With a mini incision made under the umbilicus, the abdomen was entered with a 10 mm trocar. Pneumoperitoneum was created with CO2 gas. Intra-abdominal pressure was set to 14 mmHg. Under the guidance of the laparoscope, one 10 mm trocar from the subxiphoid area and two more 5 mm trocars from the subcostal area were inserted. The cystic artery and cystic duct were clipped and cut by exposing the Callot triangle. Then the gallbladder was separated from the liver bed and taken out of the abdomen. The CO2 in the abdomen was evacuated and the trocars were removed. The fascia defect and skin were closed and the operation was terminated. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years old,
- ASA (American Society of Anesthesiologists) I-II,
- patients who will undergo laparoscopic cholecystectomy with the diagnosis of symptomatic cholelithiasis or TEP due to inguinal hernia.
Key exclusion criteria (7 listed)
- patients who were switched to open surgery,
- glaucoma, corneal disease, eye surgery,
- cerebrovascular disease,
- any neurological disease,
- chronic kidney disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea)ONSD measurement will be made using the E-CUBE i7 ultrasound system. | Device | extraperitoneal surgery group - TEP inguinal hernia repair, transperitoneal surgery group - laparoscopic cholecystectomy |
Primary outcome
measurements of optic nerve sheath diameter (ONSD)
Time frame: during surgery
mm
4 secondary outcomes
heart rate value
Time frame: during surgery
blood pressure
Time frame: during surgery
SPO2 measurements
Time frame: during surgery
ETCO2 measurements
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Background: PubMed 28722845Steiner CA, Karaca Z, Moore BJ, Imshaug MC, Pickens G. Surgeries in Hospital-Based Ambulatory Surgery and Hospital Inpatient Settings, 2014. 2017 May [updated 2020 Jul 20]. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #223. Available from http://www.ncbi.nlm.nih.gov/books/NBK442035/
- Background: PubMed 31813477Montorfano L, Giambartolomei G, Funes DR, Lo Menzo E, Dip F, White KP, Rosenthal RJ. The Cushing reflex and the vasopressin-mediated hemodynamic response to increased intracranial pressure during acute elevations in intraabdominal pressure. Surgery. 2020 Feb;167(2):478-483. doi: 10.1016/j.surg.2019.10.006. Epub 2019 Dec 6.
- Background: PubMed 9660022Rosenthal RJ, Friedman RL, Chidambaram A, Khan AM, Martz J, Shi Q, Nussbaum M. Effects of hyperventilation and hypoventilation on PaCO2 and intracranial pressure during acute elevations of intraabdominal pressure with CO2 pneumoperitoneum: large animal observations. J Am Coll Surg. 1998 Jul;187(1):32-8. doi: 10.1016/s1072-7515(98)00126-4.
- Background: PubMed 31617096Yashwashi T, Kaman L, Kajal K, Dahiya D, Gupta A, Meena SC, Singh K, Reddy A. Effects of low- and high-pressure carbon dioxide pneumoperitoneum on intracranial pressure during laparoscopic cholecystectomy. Surg Endosc. 2020 Oct;34(10):4369-4373. doi: 10.1007/s00464-019-07207-w. Epub 2019 Oct 15.
- Background: PubMed 27956677Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.
- Background: PubMed 20167583Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18.
- Background: PubMed 11445709Citerio G, Vascotto E, Villa F, Celotti S, Pesenti A. Induced abdominal compartment syndrome increases intracranial pressure in neurotrauma patients: a prospective study. Crit Care Med. 2001 Jul;29(7):1466-71. doi: 10.1097/00003246-200107000-00027.
- Background: PubMed 9094281Rosenthal RJ, Hiatt JR, Phillips EH, Hewitt W, Demetriou AA, Grode M. Intracranial pressure. Effects of pneumoperitoneum in a large-animal model. Surg Endosc. 1997 Apr;11(4):376-80. doi: 10.1007/s004649900367.
- Background: PubMed 25899811Dip F, Nguyen D, Rosales A, Sasson M, Lo Menzo E, Szomstein S, Rosenthal R. Impact of controlled intraabdominal pressure on the optic nerve sheath diameter during laparoscopic procedures. Surg Endosc. 2016 Jan;30(1):44-9. doi: 10.1007/s00464-015-4159-0. Epub 2015 Apr 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-CUBE i7 ultrasound system (Alpinion Medical Systems, Seoul, Republic of Korea) in people with Intracranial Pressure Increase, run by Konya City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurements of optic nerve sheath diameter (ONSD) (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668208, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.