The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis.

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Substudy of the RECOVER trial (a randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery) investigating innate immune homeostasis after laparoscopic colorectal surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Bromides; Rocuronium

Criteria

Inclusion Criteria:

• Scheduled for laparoscopic colorectal surgery with a primary anastomosis

• Obtained informed consent

• Age over 18 years

Exclusion Criteria:

• Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires

• Primary colostomy

• Neo-adjuvant chemotherapy

• Chronic use of analgesics or psychotropic drugs

• Use of NSAIDs shorter than 5 days before surgery

• Known or suspected allergy to rocuronium of sugammadex

• Neuromuscular disease

• Indication for rapid sequence induction

• Severe liver- or renal disease (creatinine clearance <30ml/min)

• BMI >35 kg/m²

• Deficiency of vitamin K dependent clotting factors or coagulopathy