RADOX' Reduced Abdominal Distension and Oxygen Delivery

NCT02045680 | Unknown DMC

• 2 other identifiers: 13SURN0014MISP Database 50339
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Increasing oxygen delivery, measured using oesophageal doppler monitoring of cardiovascular variables intraoperatively
2. 2.Allowing surgery at lower abdominal insufflation pressures if they have a deep block
3. 3.Reducing patient's analgesic requirements postoperatively in recovery and at 4 hours

Conditions

Colorectal Cancer

Keywords

colorectal cancer; laparoscopy; neuromuscular block; oxygen delivery

Outcome Measures

Primary Outcomes (1)

• Improved tissue oxygen delivery

  Improved tissue oxygen delivery during laparoscopic surgery in patients treated with deep neuromuscular blockade with lower operative abdominal pressures.

  Duration of surgery

Secondary Outcomes (3)

• Reduction in patient pain scores following surgery

  first 48 hours after surgery

• Time spent in recovery until fit for discharge to the wards following surgery

  Number of minutes in recovery before being discharged

• Time taken for patient to first mobilise following surgery

  First mobilisation following surgery -

Study Arms (2)

deep block

deep block

non deep block (historical control)

non deep block (historical control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective laparoscopic colorectal surgery over the age of 18years

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Michael Scott: lead
• Royal Surrey County Hospital NHS Foundation Trust: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

RECRUITING

Related Publications (1)

• Levy 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 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• michael Scott, MB ChB

  Royal Surrey County Hospital, Guildford, UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

michael scott, Mb ChB

CONTACT

441483571122; mjpscott@btinternet.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Anaesthesia and Intensive Care Medicine

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: January 27, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

GB (1)