Effectiveness of Sugammadex in LMS Surgery

NCT02329964 | Unknown Phase 4 Results DMC

• 1 other identifier: LMS-sugammadex study KoreaUH
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is comparing of rocuronium-sugammadex and succinylcholine during LMS surgery that is characterized by short operation time, required intense paralysis and ambulatory setting, has not been investigated.

Conditions

Muscle Relaxation

Keywords

Rocuronium; Sugammadex; Succinylcholine; Cisatracurium; Neostigmine; acceleromyography (TOF-Watch®)

Outcome Measures

Primary Outcomes (4)

• Recovery of T1 to 90%

  we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.

  from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes

• Surgical Rating Score

  describe by surgeon under his subjective opinion. 1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions

  during surgery

• Addition of Neuromuscular Blocking Agents

  Repeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed. In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery. We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery

  during surgery

• Recovery of T1 to 10%

  we measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.

  from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes

Secondary Outcomes (3)

• Time to Extubation

  from the end of surgery to extubate a tracheal tube

• Time to First Spontaneous Breath

  from end of surgery to first spontaneous breaths

• Time to Eye Opening

  from end of surgery to opening of the eyes to verbal commands

Other Outcomes (2)

• Length of Stay in te Operating Room

  time from in to out of the operating room

• Anesthesia Time

  from the anesthesia start to end

Study Arms (2)

R-S group

EXPERIMENTAL

Rocuronium-Sugammadex group 1. Induction of anesthesia : 1% propofol 1.5-2.5 mg/kg with fentanyl 1.5 mcg/kg 2. Muscle relaxant agent : Rocuronium 1mg/kg 3. After endotracheal intubation : normal saline(0.025 ml/kg) 4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery : Rocuronium 0.15mg/kg 5. Relaxant agent reversal. at the the end of surgery : sugammadex 2mg/kg

Drug: Sugammadex

S-C-N group

ACTIVE COMPARATOR

Succinylcholine-Cisatracurium-Neostigmine group 1. Induction of anesthesia :1% propofol 1.5-2.5 mg/kg with fentanyl 1.5 mcg/kg 2. Muscle relaxant agent :Succinylcholine 1mg/kg 3. After endotracheal intubation : Cisatracurium 0.08mg/kg 4. Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery : Succinylcholine 10mg 5. Relaxant agent reversal at the appearance of second TOF twitch (T2) : Neostigmine 0.2mg/kg with atropine 10 mcg/kg (for preventing side effects of neostigmine)

Drug: Neostigmine

Interventions

Sugammadex DRUG

Sugammadex 2mg/kg was injected to patients to R-S group, as reversal of neuromuscular blockade.

Also known as: Bridion

R-S group

Neostigmine DRUG

Neostigmine (pyridostigmine) 0.2 mg/kg mg was injected to patients to S-C-N group, as reversal of neuromuscular blockade.

Also known as: Pyridostigmine(Pyrinol)

S-C-N group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist\[ASA\] class 1-3
• scheduled Laser microlaryngeal surgery under general anesthesia
• written informed consent

You may not qualify if:

• suspected difficult tracheal intubation
• disorder affecting neuromuscular blockade
• known or suspected significant renal dysfunction
• known or suspected severe hepatic dysfunction
• history of malignant hyperthermia
• allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia
• contraindication to pyridostigmine and/or atropine
• pregnancy
• breast feeding
• body mass index \> 27kg/m2

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Related Publications (1)

• Lee C, Jahr JS, Candiotti KA, Warriner B, Zornow MH, Naguib M. Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Anesthesiology. 2009 May;110(5):1020-5. doi: 10.1097/ALN.0b013e31819dabb0.

  PMID: 19387176 RESULT

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Limitations and Caveats

The surgical rating score was assessed on the basis of the degree of laryngx exposure. This was influenced not only by neuromuscular relaxation but also by anatomical factors.

Results Point of Contact

• Title: Seolju Park
• Organization: Korea University Anam Hospital

gursla2@naver.com

+82-10-6314-6013

Study Officials

• Jangeun Cho, M.D.,Ph.D.

  Anesthesia and pain medicine department, Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: December 27, 2014
• First Posted: January 1, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2016
• Last Updated: September 28, 2015
• Results First Posted: September 28, 2015

Record last verified: 2015-08