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Recovery Times of Half Dose Sugammadex and Neostigmine for Rocuronium-induced Neuromuscular Blockade

ConditionsNeuromuscular Blocking AgentsReversal of Neuromuscular BlockadeRecovery Time
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-59
SponsorUniversitas Padjadjaran

About this trial

In operating procedure with general anesthesia muscle relaxant is usually used to increase success rate of the operation and to give better outcome. The use of reversal drugs aims to reduce the risk of post-operative complications due to muscle relaxants. Neostigmine is commonly used as a reversal drug, but its indirect mechanism of action results in a long and unpredictable recovery time. Sugammadex directly bind and inactivate rocuronium, in which resulting in a faster and predictable recovery time. However, the high price limits the use of sugammadex.

This study aims to compare the effect of half dose sugammadex and neostigmine against the moderate neuromuscular blockade of rocuronium.

The main questions it aims to answer are:

Does half dose sugammadex gives faster recovery time? Researchers will compare sugammadex to neostigmine to see if sugammadex gives faster recovery time.

Participants will:

Be given sugammadex or neostigmine as a reversal drug after the operation done

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who underwent laparoscopic cholecystectomy under general anesthesia

Using muscle relaxant rocuronium

Aged 18-59 years

American Society of Anesthesiologists (ASA) physical status classification of 1 or 2.

Disqualifiers

History of drug allergies to the agents used

Renal dysfunction

Musculoskeletal disorders

Central nervous system disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sugammadex 1 mg/kg

    Drug

    Patient in experimental arms will receive i.v. sugammadex 1 mg/kg at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed

  • Neostigmine + Atropine

    Drug

    Patient in active comparators arms will receive i.v. neostigmine 60 mcg/kg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SugammadexExperimental treatment 1 intervention
Group B: NeostigmineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recovery time

This refers to the duration measured from the point at which a Train-of-Four Count (TOFC) of 2 is observed, indicating the administration of the reversal agent, to the achievement of a Train-of-Four Ratio (TOFR) of 90%. Train of four is a electrical stimulus pattern that describe the neuromuscular blockade depth. Acceleromyography device used to monitor the neuromuscular blockade depth. Train of Four count (TOFC) 1-3 counted as moderate neuromuscular blockade, train of count (TOFC) 0 counted as deep neuromuscular blockade, train of four count (TOFC) 4 until train of four ratio (TOFR) 89% counted as mild or minimal neuromuscular blockade, and train of four ratio (TOFR) 90% counted as adequate recovery

Time frame
1 hour

Secondary outcomes

1

Spontaneous recovery time of rocuronium

This refers to the duration measured from the administration of rocuronium to the achievement of a Train-of-Four Count (TOFC) of 1 and 2 After administration of rocuronium, subject will undergo deep neuromuscular blockade with train of four count 0. Rocuronium will undergo spontaneous degradation over a certain period, but it depends on the body's response to diffusion, redistribution, metabolism, excretion, and release from the muscle relaxant receptors. The duration from the administration of rocuronium, which causes deep neuromuscular blockade with a TOFC depth of 0, to the achievement of moderate neuromuscular blockade with TOFC depths of 1 and 2 will be measured.

Time frame
3 hours
2

Bradycardia

Assess the frequency of bradicardia after the reversal agent administered

Time frame
1 hour
3

Hypotension

Assess the frequency of hypotension (mean arterial pressure under 65) after the administration of reversal agent

Time frame
1 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitas Padjadjaran

Lead sponsor

Source ClinicalTrials.gov
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