Muscle Relax Affects Outcomes of Robotic Surgery (MORE)

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Postoperative Complications; General Anesthesia

Treatments: Other: continuous infusion; Drug: Rocuronium; Other: intermittent injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03726372

XJH-A-20180701

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 2 patient groups

deep neuromuscular blockade

Experimental group

Description:

Rocuronium, a neuromuscular blocking agent will be given by continuous infusion at a dose that reaction to train of four (TOF) stimulation is depressed to zero

Treatment:

Drug: Rocuronium

Other: continuous infusion

moderate neuromuscular blockade

Experimental group

Description:

Rocuronium, a neuromuscular blocking agent will be given at a dose by intermittent injection that reaction to train of four (TOF) stimulation is kept 1 to 2

Treatment:

Other: intermittent injection

Drug: Rocuronium