Effects of Deep Versus Moderate Neuromuscular Blockade on Intraoperative Respiratory Mechanics in Patients Undergoing Laparoscopic Renal Surgery: a Prospective, Randomized, Parallel Design Study
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Seoul St. Mary's Hospital
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Thoracopulmonary Compliance
Overview
Brief Summary
The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA I or II patients scheduled to undergo laparoscopic renal surgery
Exclusion Criteria
- •BMI ≥35 kg/m2
- •Known neuromuscular disease
- •History of chronic obstructive pulmonary disease
- •Pneumothorax
- •Bronchopleural fistula
- •Previous lung surgery
- •Previous retroperitoneal surgery
- •Hemodynamic instability
- •History of cardiopulmonary disease
- •Renal insufficiency
Arms & Interventions
dNMB group
For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium will be administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever comes first. Then, the infusion rate will be titrated according to PTC (target to keep PTC between 1 to 2). Infusion rate will be increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring will be carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9.
Intervention: Rocuronium (Drug)
mNMB group
For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium will be administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count >2, whichever comes first. Then, the infusion rate will be titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate will be increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) will be administered at the end of the surgery. Patients will be extubated when the train of four ratio is ≥0.9.
Intervention: Rocuronium (Drug)
Outcomes
Primary Outcomes
Thoracopulmonary Compliance
Time Frame: intraoperative
Was measured with a patient spirometry monitor through a flow sensor. Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP).
Secondary Outcomes
- Arterial Oxygen Tension/Inspired Oxygen Fraction(intraoperative)
- Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference(intraoperative)
- Estimated Dead Space(intraoperative)
- Pulmonary Shunt(intraoperative)
Investigators
Sanghyun Hong
Assistant professor
Seoul St. Mary's Hospital