Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics

Phase 4

Completed

• Conditions: Laparoscopy; Laparoscopic Renal Surgery; Muscle Relaxation
• Interventions: Drug: Rocuronium

• Registration Number: NCT02185339
• Lead Sponsor: Seoul St. Mary's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-27
• Study Start: 2014-07
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2016-03-30
• Results First Submitted QC: 2016-05-16
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-23
• Results First Posted: 2016-06-24
• Last Update Posted: 2016-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mNMB group	Rocuronium	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.
dNMB group	Rocuronium	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.

Primary Outcome Measures

Name	Time	Method
Thoracopulmonary Compliance	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 Outcome Measures

Name	Time	Method
Arterial Oxygen Tension/Inspired Oxygen Fraction	intraoperative	Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference	intraoperative	Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Estimated Dead Space	intraoperative	Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.
Pulmonary Shunt	intraoperative	Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.; Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of