Hemodynamic and Respiratory Variations During Laparoscopic Surgery With and Without Deep Neuromuscular Blockade.
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intraoperative Complications; Postoperative Complications; Laparoscopy; Surgical Complications From General Anesthesia; Ventilator-Induced Lung Injury
Intervention: Rocuronium (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Massachusetts General Hospital Overall contact:
Marcos Vidal Melo, MD, PhD, Phone: 617-726-8980, Email: VidalMelo.Marcos@mgh.harvard.edu
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.
Clinical Details
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.
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Ejection fraction (%)Regional change in air content (Delta Z, %) Cerebral oximetry (%)
Secondary outcome: Postoperative pain
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Marcos Vidal Melo, MD, PhD, Phone: 617-726-8980, Email: VidalMelo.Marcos@mgh.harvard.edu
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Marcos Vidal Melo, MD, PhD, Phone: 617-726-8980, Email: VidalMelo.Marcos@mgh.harvard.edu
Matthias Eikermann, MD, PhD, Sub-Investigator
Jaydev Sarma, MD, PhD, Sub-Investigator
Shahin Tabatabaei, MD, PhD, Sub-Investigator
Julio Brandao, MD, Sub-Investigator
Additional Information
Related publications: 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. 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. 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. 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.
Starting date: January 2014
Last updated: June 11, 2014
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