Effectiveness of Sugammadex in LMS Surgery

NCT ID: NCT02329964

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-09-30

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.

Detailed Description

Laser microlaryngeal surgery (LMS) requires brief and intense paralysis in the short operation time and the ambulatory setting.

The ideal muscle relaxant with rapid onset time, short duration of action and minimal side effects is not yet available.

Succinylcholine (SCC) is commonly used muscle relaxant for LMS because of its rapid onset time and short duration of action.

The use of SCC for tracheal intubation is usually followed by repeated small boluses or drip of SCC or small boluses of nondepolarizing muscle relaxants with intermediate duration.

As an alternative to SCC, the non-depolarizing neuromuscular blocking agent rocuronium can be used for LMS. The onset of rocuronium 1mg/kg is around 60s that is similar to SCC. However higher doses of rocuronium have a long duration of action; this is inappropriate in ambulatory surgery that requires rapid recovery of neuromuscular function and rapid turnover.

Sugammadex has recently been introduced as a selective relaxant-binding agent that allows for rapid reversal of rocuronium-induced neuromuscular blockade. Even profound neuromuscular block with rocuronium can be quickly antagonized with sugammadex.

After obtaining Institutional Review Board approval and written informed consent, 80 patients is enrolling in this study.

Patients is divided by two groups randomly as the Rocuronium-Sugammadex group(R-S group) and the Succinylcholine - Cisatracurium- Neostigmine group(S-C-N group) .

Anesthesia was induced with intravenous propofol 1.5-2.5 mg/kg, together with fentanyl1.5 mcg/kg After induction of anesthesia, neuromuscular monitoring is performed continuously at the adductor pollicis muscle with acceleromyography (TOF-Watch®).

Subsequently, in the R-S group, patients receive rocuronium 1mg/kg and in the S-C-N group, patients receive SCC 1mg/kg.

After T1 assessed as being zero by neuromuscular monitoring, endotracheal intubation is performed.

After endotracheal intubation, in the S-C-N group, cisatracurium 0.08mg/kg is injected and in the R-S group, the same volume of normal saline is injected.

Anesthesia is maintained with desflurane with air during the surgery. Additive dose of rocuronium 0.15mg/kg or SCC 10mg is given as necessary to ensure that neuromuscular blockade remains below T2 during surgery.

After the surgical procedure ends, patients receive sugammadex 2mg/kg in the R-S group, and pyridostigmine 0.2 mg/kg with atropine 10mcg/kg in the S-C-N group at the appearance of second TOF twitch (T2).

Patient will be assessed for the time to recovery of the TOF ratio to 0.9, surgical rating scale (1- extremely poor conditions, 2- poor conditions, 3- acceptable conditions, 4- good conditions, 5- optimal conditions), and anesthesia time.

Conditions

Muscle Relaxation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

R-S group

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

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

S-C-N group

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)

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

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

Interventions

Sugammadex

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

Intervention Type: DRUG

Neostigmine

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

Intervention Type: DRUG

Other Intervention Names

Bridion; Pyridostigmine(Pyrinol)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seol Ju, Park

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jangeun Cho, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Anesthesia and pain medicine department, Korea University Anam Hospital

References

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.

Reference Type: RESULT

PMID: 19387176 (View on PubMed)

Other Identifiers

LMS-sugammadex study KoreaUH

Identifier Type: -

Identifier Source: org_study_id