Clinical trial · Observational
RADOX' Reduced Abdominal Distension and Oxygen Delivery
Haemodynamic Changes and Oxygen Delivery in Patients Undergoing Laparoscopic Colorectal Surgery With Deep Neuromuscular Block
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The use of laparoscopic surgery is continuing to increase in colorectal resection and expected reach 80% in the next 10 years. Although laparoscopic (keyhole) or minimally invasive surgery can lead to faster recovery it can also put significant stresses on the patient's heart and cause fluctuations in blood pressure due to the extreme headdown positioning and abdominal insufflation of carbon dioxide gas. We have performed several surgical cases under deep neuromuscular block and this has allowed surgery to operate at lower abdominal pressures (from 14 down to 8 mmHg). This put less strain on the heart and allowed higher cardiac outputs. This study will look at whether deep neuromuscular block is beneficial for patients by 1. Increasing oxygen delivery, measured using oesophageal doppler monitoring of cardiovascular variables intraoperatively 2. Allowing surgery at lower abdominal insufflation pressures if they have a deep block 3. Reducing patient's analgesic requirements postoperatively in recovery and at 4 hours
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- deep block
- description
- deep block
- label
- non deep block (historical control)
- description
- non deep block (historical control)
Primary outcomes (1)
- measure
- Improved tissue oxygen delivery
- timeFrame
- Duration of surgery
- description
- Improved tissue oxygen delivery during laparoscopic surgery in patients treated with deep neuromuscular blockade with lower operative abdominal pressures.
Secondary outcomes (3)
- measure
- Reduction in patient pain scores following surgery
- timeFrame
- first 48 hours after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age * Planned elective major abdominal surgery for laparoscopic resection of colorectal cancer on the enhanced recovery programme with use of neuromuscular block Capacity to consent Exclusion Criteria: * Known oesophageal disease as a contraindication to using oesophageal Doppler probe * Known allergy/hypersensitivity to rocuronium, sugammadex or other drugs to be given in protocol. * Significant neuromuscular disease Insulin dependent diabetes with or without known autonomic dysreflexia * Any known dysautonomia
References
Publications (1)
- RESULTLevy BF, Fawcett WJ, Scott MJ, Rockall TA. Intra-operative oxygen delivery in infusion volume-optimized patients undergoing laparoscopic colorectal surgery within an enhanced recovery programme: the effect of different analgesic modalities. Colorectal Dis. 2012 Jul;14(7):887-92. doi: 10.1111/j.1463-1318.2011.02805.x. PMID 21895923