Muscle Relax Affects Outcomes of Robotic Surgery

Postoperative Complications Clinical Trial

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Official title:

Effect of Neuromuscular Blockade Protocol on Perioperative Outcomes of Robotic Laparoscopic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03726372
• Other study ID #: XJH-A-20180701
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 10, 2018
• Est. completion date: November 10, 2019

Study information

• Verified date: October 2018
• Source: Fourth Military Medical University
• Contact: Zhihong Lu
• Phone: 86-13891975018
• Email: deerlu23[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 192
• Est. completion date: November 10, 2019
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Postoperative Complications

Intervention

Drug:
• Rocuronium
rocuronium is a neuromuscular blocking agent with a duration of 40 minutes

Other:
• continuous infusion
rocuronium is continuously infused
• intermittent injection
rocuronium is intermittently given

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

References & Publications (4)

Barrio J, Errando CL, García-Ramón J, Sellés 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative major respiratory complications	incidence of pneumonia and atelectasis	from end of surgery to discharge, at an average of 4 days
Secondary	maximal airway pressure	airway pressure is titrated to as low as possible as long as the end tidal carbon dioxide partial pressure is lower than 40 mmHg	from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours
Secondary	minimal cerebral oxygen saturation	cerebral oxygen saturation is continuously monitored during surgery	from start of surgery to end of surgery, at an average of 3.5 hours
Secondary	maximal intraocular pressure	intraocular pressure is monitored every 10 minutes during surgery	from start of surgery to end of surgery, at an average of 3.5 hours
Secondary	number of surgeon asking for improving muscle relax	when the surgeon is unsatisfied with the muscle relax, he can tell the anesthetist	from start of surgery to end of surgery, at an average of 3.5 hours
Secondary	time to extubation	criteria of extubation: spontaneous respiratory rate>10 per minute and end tidal carbon dioxide partial pressure<45mmHg	from end of sevoflurane inhalation to extubation, at an average of 20 minutes
Secondary	incidence of nausea and vomiting in post-anesthesia care unit		from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
Secondary	incidence of shoulder pain in 24 hours after surgery		from end of surgery to 24 hours after surgery
Secondary	incidence of residual neuromuscular blockade in the post-anesthesia care unit	residual neuromuscular blockade is defined as time of head-lift or limb-lift<10 seconds	from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
Secondary	visual analogue scale at 24 hours after surgery	the patients are asked to mark the score they feel, 0 is no pain,100 is untolerated pain	end of surgery to 24 hours after surgery
Secondary	expense after surgery	the expense from immediately after surgery to discharge	end of the surgery to discharge,at an average of 4 days
Secondary	satisfaction score of the patients	the patient is asked to give a score between 0 and 10, 0 means not satisfied,10 means totally satisfied.	from end of surgery to discharge,at an average of 4 days