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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 ≥ 9

Proportion 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

Page last updated: August 23, 2015

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