Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics

Seoul St. Mary's Hospital

Status and phase: Completed; Phase 4

Conditions: Laparoscopy; Laparoscopic Renal Surgery; Muscle Relaxation

Treatments: Drug: Rocuronium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02185339

dNMBonResp

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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
• Asthma
• Pneumothorax
• Bronchopleural fistula
• Previous lung surgery
• Previous retroperitoneal surgery
• Hemodynamic instability
• History of cardiopulmonary disease
• Renal insufficiency

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 2 patient groups

dNMB group

Experimental group

Description:

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.

Treatment:

Drug: Rocuronium

Drug: Rocuronium

mNMB group

Active Comparator group

Description:

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.

Treatment:

Drug: Rocuronium

Drug: Rocuronium