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Muscle Relax Affects Outcomes of Robotic Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03726372
Acronym
MORE
Enrollment
192
Registered
2018-10-31
Start date
2018-11-10
Completion date
2019-11-10
Last updated
2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Postoperative Complications

Keywords

robotic surgery, laparoscopic surgery, neuromuscular blockade, postoperative complication

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.

Interventions

DRUGRocuronium

rocuronium is a neuromuscular blocking agent with a duration of 40 minutes

rocuronium is continuously infused

OTHERintermittent injection

rocuronium is intermittently given

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Muscle relaxant will be given by a specific investigator that is not involved in anesthesia and outcome assessment

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of postoperative major respiratory complicationsfrom end of surgery to discharge, at an average of 4 daysincidence of pneumonia and atelectasis

Secondary

MeasureTime frameDescription
maximal airway pressurefrom establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hoursairway pressure is titrated to as low as possible as long as the end tidal carbon dioxide partial pressure is lower than 40 mmHg
minimal cerebral oxygen saturationfrom start of surgery to end of surgery, at an average of 3.5 hourscerebral oxygen saturation is continuously monitored during surgery
maximal intraocular pressurefrom start of surgery to end of surgery, at an average of 3.5 hoursintraocular pressure is monitored every 10 minutes during surgery
number of surgeon asking for improving muscle relaxfrom start of surgery to end of surgery, at an average of 3.5 hourswhen the surgeon is unsatisfied with the muscle relax, he can tell the anesthetist
time to extubationfrom end of sevoflurane inhalation to extubation, at an average of 20 minutescriteria of extubation: spontaneous respiratory rate\>10 per minute and end tidal carbon dioxide partial pressure\<45mmHg
incidence of nausea and vomiting in post-anesthesia care unitfrom admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
incidence of residual neuromuscular blockade in the post-anesthesia care unitfrom admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutesresidual neuromuscular blockade is defined as time of head-lift or limb-lift\<10 seconds
visual analogue scale at 24 hours after surgeryend of surgery to 24 hours after surgerythe patients are asked to mark the score they feel, 0 is no pain,100 is untolerated pain
expense after surgeryend of the surgery to discharge,at an average of 4 daysthe expense from immediately after surgery to discharge
satisfaction score of the patientsfrom end of surgery to discharge,at an average of 4 daysthe patient is asked to give a score between 0 and 10, 0 means not satisfied,10 means totally satisfied.
incidence of shoulder pain in 24 hours after surgeryfrom end of surgery to 24 hours after surgery

Contacts

Primary ContactZhihong Lu
deerlu23@163.com86-13891975018
Backup ContactHailong Dong
hldong6@hotmail.com86-84775337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026