Clinical trial NCT03726372: Muscle Relax Affects Outcomes of Robotic Surgery
Official title: Effect of Neuromuscular Blockade Protocol on Perioperative Outcomes of Robotic Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Anesthesia
Postoperative Complications
Keywords: robotic surgery
laparoscopic surgery
neuromuscular blockade
postoperative complication
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: During robotic laparoscopic surgery, a high intraperitoneal pressure may result in high airway pressure and inadequate perfusion of the abdominal organs, and as a result the postoperative outcomes. Degree of neuromuscular blockade (NMB) can affect the intraperitoneal pressure. In this study, the patients undergoing robotic laparoscopic surgery will be assigned to deep NMB group and moderate NMB group. Perioperative outcomes including maximal intraperitoneal pressure, maximal intraoptic pressure, quality of emergence, postoperative pain, and incidence of postoperative respiratory complication will be compared. The results of this study will provide evidence for optimizing NMB protocol of robotic laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective robotic laparoscopic surgery under general anesthesia
* American Society of Anesthesiologists status 1-2
* Body mass index of 18-30kg/m2
* Patients scheduled to be positioned in trendelenburg position during surgery

Exclusion Criteria:

* Patients allergic to rocuronium
* Patients with neuromuscular dysfunction
* Patients with existed pulmonary diseases
* Patients with hepatic or renal dysfunction

Primary outcomes:
measure: incidence of postoperative major respiratory complications
timeFrame: from end of surgery to discharge, at an average of 4 days
Secondary outcomes:
measure: maximal airway pressure
timeFrame: from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours
measure: minimal cerebral oxygen saturation
timeFrame: from start of surgery to end of surgery, at an average of 3.5 hours
measure: maximal intraocular pressure
timeFrame: from start of surgery to end of surgery, at an average of 3.5 hours
measure: number of surgeon asking for improving muscle relax
timeFrame: from start of surgery to end of surgery, at an average of 3.5 hours
measure: time to extubation
timeFrame: from end of sevoflurane inhalation to extubation, at an average of 20 minutes
measure: incidence of nausea and vomiting in post-anesthesia care unit
timeFrame: from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
measure: incidence of shoulder pain in 24 hours after surgery
timeFrame: from end of surgery to 24 hours after surgery
measure: incidence of residual neuromuscular blockade in the post-anesthesia care unit
timeFrame: from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
measure: visual analogue scale at 24 hours after surgery
timeFrame: end of surgery to 24 hours after surgery
measure: expense after surgery
timeFrame: end of the surgery to discharge,at an average of 4 days
measure: satisfaction score of the patients
timeFrame: from end of surgery to discharge,at an average of 4 days
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Zhihong Lu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13.
citation: Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
citation: Barrio J, Errando CL, Garcia-Ramon J, Selles R, San Miguel G, Gallego J. Influence of depth of neuromuscular blockade on surgical conditions during low-pressure pneumoperitoneum laparoscopic cholecystectomy: A randomized blinded study. J Clin Anesth. 2017 Nov;42:26-30. doi: 10.1016/j.jclinane.2017.08.005. Epub 2017 Aug 30.
citation: Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.