Laparoscopic colorectal surgery
Conditions
Interventions
Trade Name: Esmeron (Rocuroniumbromide)
Pharmaceutical Form: Solution for injection
Trade Name: Bridion
Pharmaceutical Form: Solution for injection
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Scheduled for laparoscopic colorectal surgery with a primary anastomosis - Age = 18 years - Obtained informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 204 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires - Primary colostomy - Neo-adjuvant chemotherapy (substudy) - 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 35 kg/m² - Deficiency of vitamin K dependent clotting factors or coagulopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main study: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and the early quality of recovery after laparoscopic colorectal surgery with perioperative care according to the enhanced recovery principles.;Secondary Objective: Not applicable;Primary end point(s): Quality of recovery (QoR-40) questionnaire score Substudy: mononuclear cell activity ex vivo measured as IL-6 and IL-10 production upon LPS stimulation. ;Timepoint(s) of evaluation of this end point: 24 hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Quality of recovery-40 questionnaire score • McGill Pain questionnaire • RAND-36 general health questionnaire • Pain at rest and pain on movement (NRS 0-10), is pain acceptable or unacceptable, referred shoulder pain yes/no • Postoperative nausea and vomiting (NRS 0-10) • Cumulative opiate, analgesic and anti-emetics use • Length of hospital stay • Post-operative complications • Surgical conditions; the Surgical Rating Scale is used to quantify the quality of the surgical field during the pneumoperitoneum phase • Time to reach discharge criteria Substudy: • Peritoneal mesothelial hypoxia as reflected by peritoneal HIF1a mRNA expression. • Histological peritoneal mesothelial cell injury and plasma levels of DAMPs and cytokines.;Timepoint(s) of evaluation of this end point: • Quality of recovery-40 questionnaire score day 3 and 7 after surgery • McGill Pain and RAND-36 questionnaires upon admission and 3 months after surgery. • Pain scores, nausea and vomiting 1, 8, 24 and 72 hours after surgery • Cumulative opiate, analgesic and anti-emetics use and length of hospital stay at discharge • Post-operative complications after 3 months • Surgical conditions during pneumoperitoneum • Time to reach discharge criteria at 8, 24, 48 and 72 hours after surgery Substudy: • Peritoneal mesothelial hypoxia: HIF1a mRNA expression before and after pneumoperitoneum phase. • Histological peritoneal mesothelial cell injury before and after pneumoperitoneum phase, plasma DAMPs and cytokines upon admission, before and after pneumoperitoneum and 24h after surgery. | — |
Countries
Netherlands, Spain
Contacts
Public ContactRECOVER study information
Radboudumc
Outcome results
None listed