Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics

NCT02185339 | Completed Phase 4 Results

• 1 other identifier: dNMBonResp
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Renal Surgery; Laparoscopy; Muscle Relaxation

Keywords

Respiratory mechanics; Respiratory function test; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Other Outcomes (4)

• Stroke Volume Variation

  intraoperative

• Cardiac Index

  intraoperative

• Surgical Condition

  At completion of pneumoperitoneum surgery

Study Arms (2)

dNMB group

EXPERIMENTAL

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

mNMB group

ACTIVE COMPARATOR

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

Interventions

Rocuronium DRUG

Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.

Also known as: Esmeron®

dNMB group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or II patients scheduled to undergo laparoscopic renal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Sanghyun Hong
• Organization: Department of Anesthesiology and Pain Medicine, The Catholic University of Korea College of Medicine, Seoul St. Mary's Hospital

shhong7272@gmail.com

82-2-2258-2236

Study Officials

• Sang-Hyun Hong, MD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 25, 2016
• Results First Posted: June 24, 2016

Record last verified: 2016-06

Locations

KR (1)