A Phase 4 interventional study of Sugammadex and Neostigmine in Muscle Relaxation, sponsored by Korea University Anam Hospital. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-28.
Sponsored by Korea University Anam Hospital · Phase 4, Interventional, and Supportive care
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.
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.
Korea University Anam Hospital is the lead sponsor of 110 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Sugammadex 2mg/kg was injected to patients to R-S group, as reversal of neuromuscular blockade.
Also known as: Bridion
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)
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes
Time to Extubation
We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation
Time frame: from the end of surgery to extubate a tracheal tube
Time to First Spontaneous Breath
time from end of surgery to first spontaneous breaths
Time frame: from end of surgery to first spontaneous breaths
Time to Eye Opening
We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands.
Time frame: from end of surgery to opening of the eyes to verbal commands
Length of Stay in te Operating Room
LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group.
Time frame: time from in to out of the operating room
Anesthesia Time
time from propofol injection to extubation
Time frame: from the anesthesia start to end
Recruitment period : 2015.2.10 - 2015.6.30 Location : Korea University Medical Center Anam Hospital
| Milestone | R-S Group | S-C-N Group |
|---|---|---|
| Started | 40 | 40 |
| Completed | 40 | 40 |
| Not completed | 0 | 0 |
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.
| seconds | R-S Group | S-C-N Group |
|---|---|---|
| Recovery of T1 to 90% | 377 (334 to 435) | 240 (180 to 360) |
describe by surgeon under his subjective opinion. 1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions
| score | R-S Group | S-C-N Group |
|---|---|---|
| Surgical Rating Score | 5.0 (5.0 to 5.0) | 5.0 (4.0 to 5.0) |
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
| participants | R-S Group | S-C-N Group |
|---|---|---|
| Addition of Neuromuscular Blocking Agents | 0 | 20 |
We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation
| seconds | R-S Group | S-C-N Group |
|---|---|---|
| Time to Extubation | 430 (366 to 510) | 380 (286 to 495) |
LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group.
| minutes | R-S Group | S-C-N Group |
|---|---|---|
| Length of Stay in te Operating Room | 31.0 ± 7.7 | 38.6 ± 7.5 |
time from propofol injection to extubation
| minutes | R-S Group | S-C-N Group |
|---|---|---|
| Anesthesia Time | 28.4 ± 7.5 | 35.2 ± 7.0 |
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.
| seconds | R-S Group | S-C-N Group |
|---|---|---|
| Recovery of T1 to 10% | 271 (183 to 330) | 190 (105 to 300) |
time from end of surgery to first spontaneous breaths
| seconds | R-S Group | S-C-N Group |
|---|---|---|
| Time to First Spontaneous Breath | 263 (175 to 334) | 240 (70 to 325) |
We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands.
| seconds | R-S Group | S-C-N Group |
|---|---|---|
| Time to Eye Opening | 340 (200 to 517) | 300 (180 to 420) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| R-S Group | — | 0/40 (0%) | 0/40 (0%) |
| S-C-N Group | — | 0/40 (0%) | 0/40 (0%) |
| Age, Categorical(Participants) | R-S Group | S-C-N Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 37 | 32 | 69 |
| >=65 years | 3 | 8 | 11 |
| Age, Continuous(years) | R-S Group | S-C-N Group | Total |
|---|---|---|---|
| Mean | 48 ± 12 | 52 ± 15 | 50 ± 13 |
| Sex: Female, Male(Participants) | R-S Group | S-C-N Group | Total |
|---|---|---|---|
| Female | 18 | 16 | 34 |
| Male | 22 | 24 | 46 |
No study locations are listed for this record.
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Korea University Anam Hospital