Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics

Effects of Deep Versus Moderate Neuromuscular Blockade on Intraoperative Respiratory Mechanics in Patients Undergoing Laparoscopic Renal Surgery: a Prospective, Randomized, Parallel Design Study

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 Overview

• Status: Completed
• Conditions: Laparoscopic Renal Surgery; Laparoscopy; Muscle Relaxation
• Intervention / Treatment: Drug: Rocuronium; Drug: Rocuronium

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-701
    • Seoul St. Mary'S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Rocuronium; Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.; Other Names: Esmeron®; Drug: Rocuronium; Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.; Other Names: Esmeron®
Active Comparator: 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.	Drug: Rocuronium; Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.; Other Names: Esmeron®; Drug: Rocuronium; Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.; Other Names: Esmeron®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thoracopulmonary Compliance	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).	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Oxygen Tension/Inspired Oxygen Fraction	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.	intraoperative
Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference	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.	intraoperative
Estimated Dead Space	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.	intraoperative
Pulmonary Shunt	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.	intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Volume Variation	Was calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.	intraoperative
Cardiac Index	Was obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.	intraoperative
Surgical Condition	Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)	At completion of pneumoperitoneum surgery
Postoperative Pain	Postoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 10). Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h.	Postoperative 2 days

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Sang-Hyun Hong, MD, Seoul St. Mary'S Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): July 25, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Respiratory mechanics; Respiratory function test; Hemodynamics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: dNMBonResp

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No