Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures
Information source: Chulalongkorn University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Laryngoscopic Surgical Procedures
Intervention: Deep Neuromuscular Blockade (Procedure); Moderate Neuromuscular Blockade (Procedure); Sugammadex (Drug); Rocuronium (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Chulalongkorn University Official(s) and/or principal investigator(s): Oraluxna Rodanant, MD, Principal Investigator, Affiliation: Anesthesiology Department, Faculty of Medicine, Culalongkorn University.
Overall contact: Oraluxna Rodanant, MD., Phone: +662-256 4215, +662-256 4295, Email: drtuen@yahoo.com
Summary
It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex
as an reversal in endolaryngeal surgery.
We will conduct a clinical study aiming to compare two treatment strategies; Deep
neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB
will offer better stillness. We will also descriptively examine if patients would be safely
discharged from a recovery room.
Clinical Details
Official title: A Comparison of Surgical Conditions Between Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Proportion of patients who have a surgical conditions score of excellent
Secondary outcome: Proportion of patients who are ready to be discharged from post- operative care, defined as Modified Aldrete's score ≥ 9Proportion of patients who are ready to be discharged from operating room, defined as TOF > 0.9 Frequency of clinical signs of early recovery during endolaryngeal Procedures.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female aged 18 - 60 years; ASA I-III.
- Subjects have been planned for elective endolaryngeal. Procedures (Direct
Laryngoscopy with laser (micro-)surgery in patients with Tis, T1, T2, supraglottis
and glottis carcinoma)
Exclusion Criteria:
- Any renal impairment (CrCL < 80 ml/ min)
- Any hepatic impairment; Child Pugh A, B or C
- BMI > 30 kg m2
- Known or suspected generalized neuromuscular disorders
- Allergies to Rocuronium, Sugammadex, Sevoflurane, Propofol, fentanyl used during
general anesthesia
- Hypersensitivity to the active substance or to any of the excipients
- Female patient who are pregnant and breastfeeding.
- Patient with poor Glasgow Coma Score and mental derangement who is unable to give
informed consent.
- Patient with Tracheostomy tube.
Locations and Contacts
Oraluxna Rodanant, MD., Phone: +662-256 4215, +662-256 4295, Email: drtuen@yahoo.com Additional Information
Starting date: July 2015
Last updated: May 20, 2015
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