Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Dilatation, Pathologic

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

michael scott, Mb ChB

Michael Scott

Sarah Tracey

Katie Blightman, MB BS FRCA

michael Scott, MB ChB

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

Design pilot study, single arm controlled study Hypothesis Deep neuromuscular blockade provided intraoperatively for patients undergoing laparoscopic colorectal surgery will have an increase in oxygen delivery as measured by haemodynamic data using oesophageal doppler. Secondary hypotheses Deep muscular blockade will provide the same surgical operating conditions at lower abdominal inflation pressures. The patients will experience less pain postoperatively due to less forced distension of the peritoneum demonstrated by less analgesic requirements. Patients will therefore spend less time in recovery and be able to mobilise earlier.Participants and Recruitment Patients will be assessed in preassessment clinic by a clinical nurse specialist for eligibility and provided with a patient information sheet. On the morning of planned surgery patients eligible who wish to be included in the study will be consented for the study in accordance with the International GCP guidelines by the anaesthetic researcher, and given a form to sign.

Sample size We estimate that 30- 40 participants will be required to demonstrate and statistical significance. Our unit carries out approximately 4 laparoscopic colorectal resections per week. Assuming that 30% of patients may not consent to participation or will not meet inclusion criteria we predict it will take less than 6- 12 months to enrol the necessary number of participants.

Preoperatively Participants will already be on the standardised Enhanced Recovery Programme. Intraoperatively An oesophageal Doppler probe will be inserted orally or nasally (standard practice in our unit for haemodynamic monitoring) to titrate fluids using stroke volume optimisation protocol (as per normal practice). Cardiovascular variables (heart rate, stroke volume, blood pressure and corrected flow time) will be collected prior to commencing surgery to provide baseline data set and throughout the procedure in accordance with routine observations under anaesthesia, which will together calculate oxygen delivery. Abdominal pressure will be measured continuously during insufflation and maintenance of the pneumoperitoneum (as per standard practice). Abdominal insufflation pressure will be gradually reduced as low as possible but ensuring the same standard of surgical access and operating conditions. Following completion of surgery the neuromuscular blockade will be reversed using a standardised dose of sugammadex 4mg/ kg according to the manufacturers guidelines according to neuromuscular monitoring returns a double burst stimulus to normal.

Postoperatively Immediately in the recovery area analgesia will be provided in accordance with enhanced recovery guidelines. Morphine Sulphate will be titrated to effect and a patient controlled analgesia pump given to the patient, which records quantity and demands of morphine used. .The standard enhanced recovery pathway will then be continued until discharge home.

Outcome measures Data collection for the primary endpoint will be collected from the haemodynamic data captured in theatre using the anaesthetic chart recording and oesophageal doppler. Data for the secondary endpoints will be pain scores in recovery and at 4 hours post operatively. Other secondary endpoints will be collected as standard by the Enhanced Recovery Nurse. These will include: length of operation, time spent in recovery area after surgery, time taken until mobilisation.

RADOX' Reduced Abdominal Distension and Oxygen Delivery

Haemodynamic Changes and Oxygen Delivery in Patients Undergoing Laparoscopic Colorectal Surgery With Deep Neuromuscular Block

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

Pain scores in recovery area following surgery using the standard Royal Surrey pain scoring system. This will continue three times a day for 48 hours

time taken in minutes until mobilisation achieved

Royal Surrey County Hospital NHS Foundation Trust

Merck Sharp & Dohme LLC

Dr Michael Scott

Consultant in Anaesthesia and Intensive Care Medicine

Head and Neck Neoplasms

All Drugs and Chemicals

Anti-Arrhythmia Agents

Channel Blockers

Analgesics

Anticonvulsants

Central Nervous System Depressants

Reproductive Control Agents

Bone Density Conservation Agents

Rocuronium

Magnesium Sulfate

Anesthetics

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Tocolytic Agents

In the magnesium group, patients received MgSO4 30 mg/kg in 0.9% physiological saline (total volume 100 ml) intravenously, for 10 min, and then continuous intravenous infusion of MgSO4 at a rate of 1 g/h during the surgical procedure until the maximum of 3 h.

Controls received 100 ml of 0.9% physiological saline, for 10 min, and then continuous intravenous infusion of saline at a rate of 33 ml/h during the surgical procedure until the maximum of 3 h.

MgSO4 30 mg/kg in 0.9% physiological saline (total volume 100 ml) intravenously, for 10 min, and then continuous intravenous infusion of MgSO4 at a rate of 1 g/h during the surgical procedure until the maximum of 3 h

100 ml of 0.9% physiological saline, for 10 min, and then continuous intravenous infusion of saline at a rate of 33 ml/h during the surgical procedure until the maximum of 3 h

Placebo

Pedro Rotava, MD

The purpose of this study is to evaluate the effects of MgSO4 administration on the pharmacodynamics of rocuronium in patients with 60 or more years of age.

Magnesium Sulphate and Rocuronium in Patients Over 60

Effects of Magnesium Sulphate on the Pharmacodynamics of Rocuronium in Patients 60 Years or Older: Randomised and Double-Blind Study

Time from the start of injection of rocuronium until TOF ratio 0.9

Time from the start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF

Time from the start of injection of rocuronium until T1 of the TOF had recovered to 25% of the initial T1 value

Time between 25% and 75% recovery of the initial T1 value

Time between 25% recovery of the initial T1 value and a TOF ratio of 0.9

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RADOX' Reduced Abdominal Distension and Oxygen Delivery	NCT02045680	Colorectal Canc...		18 Years -	Royal Surrey County Hospital NHS Foundation Trust
Magnesium Sulphate and Rocuronium in Patients Over 60	NCT01804205	Head and Neck C...	Magnesium Sulfa... Placebo	60 Years -	Instituto Nacional de Cancer, Brazil
Magnesium Sulphate and Rocuronium in Patients Over 60	NCT01804205	Head and Neck C...	Magnesium Sulfa... Placebo	60 Years -	Instituto Nacional de Cancer, Brazil
RADOX' Reduced Abdominal Distension and Oxygen Delivery	NCT02045680	Colorectal Canc...		18 Years -	Royal Surrey County Hospital NHS Foundation Trust

Spots Global Cancer Trial Database for neuromuscular block