Low Pressure Pneumoperitoneum and Deep Neuromuscular Block vs. Standard During RARP to Improve Quality of Recovery; a Randomized Controlled Study. (RECOVER-2)

Radboud University Medical Center

Status: Completed

Conditions: Postoperative Complications; Immune System Tolerance; Quality of Life; Acute Pain

Treatments: Other: Standard intra-abdominal pressure; Other: Low intra-abdominal pressure; Other: Moderate neuromuscular blockade (NMB); Other: Deep neuromuscular blockade (NMB)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04250883

2020-000411-79 (EudraCT Number)

NL72780.091.20

Details and patient eligibility

About

Intra-abdominal pressure (IAP) needed to create sufficient workspace during laparoscopic surgery affects the surrounding organs with ischemia-reperfusion injury and a systemic immune response. This effect is related to postoperative recovery, pain scores, opioid consumption, bowel function recovery, morbidity and possibly mortality. In clinical practice standard pressures of 12-16mmHg are applied instead of the lowest possible IAP, but accumulating evidence shows lower pressure pneumoperitoneum (PNP) (6-8mmHg) to be non-compromising for sufficient workspace, when combined with deep neuromuscular blockade (NMB) in a vast majority of patients. Therefore, low impact laparoscopy, meaning low pressure PNP facilitated by deep NMB, could be a valuable addition to Enhanced Recovery After Surgery (ERAS) Protocols.

The use of low pressure PNP may also reduce hypoxic injury and the release of DAMPs and thereby contributing to a better preservation of innate immune function which may help to reduce the risk of infectious complications.

The participants will be randomly assigned to one of the experimental groups with low impact laparoscopy or one of the control groups with standard laparoscopy.

Full description

Intra-abdominal pressure (IAP) needed to create sufficient workspace during laparoscopic surgery affects the surrounding organs with ischemia-reperfusion injury and a systemic immune response. This effect is related to postoperative recovery, pain scores, opioid consumption, bowel function recovery, morbidity and possibly mortality. Therefore, low impact laparoscopy, meaning low pressure PNP facilitated by deep NMB, could be a valuable addition to Enhanced Recovery After Surgery (ERAS) Protocols.

The use of low pressure PNP may also reduce hypoxic injury and the release of DAMPs and thereby contributing to a better preservation of innate immune function which may help to reduce the risk of infectious complications.

The participants will be randomly assigned to the experimental group 1: low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2)); 8 mmHg IAP after trocar introduction for perfusion measurement or the experimental group 2: low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2)); 12 mmHg IAP after trocar introduction for perfusion measurement, or control group 1: standard laparoscopy (standard pressure (12 mmHg) and moderate NMB (TOF 1-2)); 8 mmHg IAP after trocar introduction for perfusion measurement, or control group 2: standard laparoscopy (standard pressure (12 mmHg) and moderate NMB (TOF 1-2)); 12 mmHg IAP after trocar introduction for perfusion measurement.

ICG injection will take place with starting pressure to quantify parietal peritoneum perfusion, and a parietal peritoneal biopsy will be taken. At the end of surgery, a second parietal peritoneum biopsy will be taken.

NB: After introduction of the camera trocar, insufflation of carbon dioxide is titrated to an IAP of 8mmHg in group A and C, and 14 mmHg in group B and D. After placement of the last trocar the injection of ICG and video registration of peritoneum will take place, and a peritoneal biopsy will be taken. There after surgery will take place with an IAP of 14mmHg in the control groups (C and D), and an IAP of 8mmHg in the experimental groups (A and B). In the control groups (C and D)

Pre- and postoperative a few questionnaires will be taken and blood withdrawals to evaluate the quality of recovery, and the immune response.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Age ≥ 18 years
• Undergoing elective robot assisted radical prostatectomy (RARP)
• Obtained informed consent

Exclusion criteria

• Laparoscopic radical prostatectomy without robot assistance
• Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires
• Neo-adjuvant chemotherapy
• Chronic use of analgesics or psychotropic drugs
• Use of NSAID's shorter than 5 days before surgery
• Severe liver- or renal disease
• Neuromuscular disease
• Hyperthyroidism or thyroid adenomas
• Deficiency of vitamin K dependent clotting factors or coagulopathy
• Planned diagnostics or treatment with radioactive iodine < 1 week after surgery
• Indication for rapid sequence induction
• BMI >35kg/m2
• Known of suspected hypersensitivity to ICG, sodium iodide, iodine, rocuronium or sugammadex
• Use of medication interfering with ICG absorption as listed in the summary of product characteristics (SPC); anticonvulsants, bisulphite compounds, haloperidol, heroin, meperidine, metamizol, methadone, morphium, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, cyclopropane, probencid

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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97 participants in 2 patient groups

Experimental group: Low Impact laparoscopy

Experimental group

Description:

low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2)

Treatment:

Other: Deep neuromuscular blockade (NMB)

Other: Low intra-abdominal pressure

Control group: Standard laparoscopy

Active Comparator group

Description:

standard laparoscopy (standard pressure (14 mmHg) and moderate NMB (TOF 1-2)

Treatment:

Other: Moderate neuromuscular blockade (NMB)

Other: Standard intra-abdominal pressure