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Effects of Different Pneumoperitoneum Pressures on Cerebral Oxygen Metabolism in Infants during Laparoscopic Surgery

Effects of Different Pneumoperitoneum Pressures on Cerebral Oxygen Metabolism in Infants during Laparoscopic Surgery

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117074
Enrollment
Unknown
Registered
2026-01-19
Start date
2026-01-19
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital duodenal obstruction, Hypertrophic pyloric stenosis, Hypertrophic pyloric stenosis, Biliary atresia, Congenital hydronephrosis

Interventions

Group A:Group A set the pneumoperitoneum pressure at 3 mmHg, The pneumoperitoneum pressure was adjusted according to the laparoscopic field conditions. When the field was clear, the pneumoperitoneum
Group B:Group B set the pneumoperitoneum pressure at 5 mmHg, The pneumoperitoneum pressure was adjusted according to the laparoscopic field conditions. When the field was clear, the pneumoperitoneum p

Sponsors

Children's Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.1 Years to 1 Years

Inclusion criteria

Inclusion criteria: 1. children diagnosed with congenital duodenal obstruction, congenital megacolon, hypertrophic pyloric stenosis, congenital biliary atresia, congenital hydronephrosis 2. Age 1 to 12 months after birth; 3. Weight >= 2500g; 4. 1min and 5min postnatal Apgar score >10 points; 5. those with ASA anaesthesia classification of grade I; 6. Those who were operated for the first time.

Exclusion criteria

Exclusion criteria: 1. History of birth trauma and intrauterine distress; 2. Cases presenting with intestinal torsion necrosis or signs of strangulating intestinal obstruction; 3. Cases with concomitant congenital anomalies; 4. Cases with concomitant hypoxic-ischaemic encephalopathy (HIE) or intracranial haemorrhage; 5. Cases with abnormal red blood cell count, haemoglobin levels, or haematocrit.

Design outcomes

Primary

MeasureTime frame
Inflatable pressure value;regional cerebral oxygen saturation;splanchnic oxygen saturation;

Secondary

MeasureTime frame
Air intake volume; Systolic Blood Pressure;Heart Rate;Airway Pressure;End-tidal Carbon dioxide Pressure;Peripheral capillary oxygen saturation;Operation time;Pneumoperitoneum duration;Recovery time;Intraoperative blood loss;

Countries

China

Contacts

Public ContactCHEN Chunmei

Children's Hospital of Nanjing Medical University

1478064923@qq.com+86 189 5176 9829

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026