Hemodynamic and Respiratory Variations During Laparoscopic Surgery With and Without Deep Neuromuscular Blockade.

Postoperative Complications Clinical Trial

Official title:

A Prospective, Double-blind, Randomized, Crossover Design Study to Compare the Hemodynamic and Respiratory Variations During Laparoscopic Surgery in Patients With and Without Deep Neuromuscular Blockade.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025075
• Other study ID #: Merck-50706
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: February 3, 2016
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to investigate the effect of depth of neuromuscular block (NMB) on global and regional (dependent versus nondependent) respiratory mechanics during laparoscopic surgery. Furthermore, we will investigate if the level of NMB influences intraoperative hemodynamic and cerebral oxygenation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Elective patients scheduled to undergo laparoscopic surgery with expected duration > 2h

• Physical status ASA I - III

Exclusion Criteria:

• Pregnancy

• Severe cardiac disease (NYHA class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmia)

• Previous lung surgery

• History of severe chronic obstructive pulmonary disease

• Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery including bypass/banding, history of esophageal varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)

• Mechanical ventilation within the last 30 days

• Neuromuscular disease

• Consented for another interventional study or refusal to participate in the present study

• Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Intraoperative Complications
• Laparoscopy
• Lung Injury
• Postoperative Complications
• Surgical Complications From General Anesthesia
• Ventilator-Induced Lung Injury

Intervention

Drug:
• Rocuronium
Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB).

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Dexter SP, Vucevic M, Gibson J, McMahon MJ. Hemodynamic consequences of high- and low-pressure capnoperitoneum during laparoscopic cholecystectomy. Surg Endosc. 1999 Apr;13(4):376-81. — View Citation

Ivankovich AD, Miletich DJ, Albrecht RF, Heyman HJ, Bonnet RF. Cardiovascular effects of intraperitoneal insufflation with carbon dioxide and nitrous oxide in the dog. Anesthesiology. 1975 Mar;42(3):281-7. — View Citation

Joris J, Cigarini I, Legrand M, Jacquet N, De Groote D, Franchimont P, Lamy M. Metabolic and respiratory changes after cholecystectomy performed via laparotomy or laparoscopy. Br J Anaesth. 1992 Oct;69(4):341-5. — View Citation

Karsten J, Heinze H, Meier T. Impact of PEEP during laparoscopic surgery on early postoperative ventilation distribution visualized by electrical impedance tomography. Minerva Anestesiol. 2014 Feb;80(2):158-66. Epub 2013 Jul 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection fraction (%)	To assess cardiac performance, transthoracic echocardiography will be used.	The outcome measure will be assessed intraoperatively following introduction of pneumoperitoneum and positioning as the change from the conditions of deep to the condition of mild muscle relaxation as defined by TOF and post-tetanic twitches.	No
Primary	Regional change in air content (Delta Z, %)	We will measure continuous respiratory flows and pressures in the intraoperative period to assess continuously the compliance and resistance of the respiratory system (T1 to T5). In addition, we will use an esophageal balloon to assess esophageal pressures and partition the global mechanical properties of the respiratory system, into their lung and chest wall components (T1 to T5). Regional lung aeration will be assessed for quantification of intraoperative lung recruitment using Electrical Impedance Tomography (EIT) (T0 to T6).	The outcome measure will be assessed intraoperatively following introduction of pneumoperitoneum and positioning as the change from the conditions of deep to the condition of mild muscle relaxation as defined by TOF and post-tetanic twitches.	No
Primary	Cerebral oximetry (%)	Regional cerebral oxygenation will be assessed continuously during the intraoperative period using NIRS technology.	The outcome measure will be assessed intraoperatively following introduction of pneumoperitoneum and positioning as the change from the conditions of deep to the condition of mild muscle relaxation as defined by TOF and post-tetanic twitches.	Yes
Secondary	Postoperative pain	The patient will be inquired about pain with a visual analogue scale (VAS). Pain will be evaluated as abdominal pain, incisional pain, shoulder pain and overall pain using VAS (0 = no pain; 100 = worst possible pain).	Postoperative Day 1	No