OPTIMALISATION OF REVERSAL CLINICAL STRATEGY WITHOUT TOF MONITORING IS EQUIVALENT TO REVERSAL CLINICAL STRATEGY USING QUANTITATIVE TOF MONITORING? COMPARISON STUDY ON INCIDENCE OF RESIDUAL PARALYSIS AT RECOVERY ROOM FOR PATIENTS RECEIVING ROCURONIUM AND SEVOFLURANE

OPTIMALISATION OF REVERSAL CLINICAL STRATEGY WITHOUT TOF MONITORING IS EQUIVALENT TO REVERSAL CLINICAL STRATEGY USING QUANTITATIVE TOF MONITORING? COMPARISON STUDY ON INCIDENCE OF RESIDUAL PARALYSIS AT RECOVERY ROOM FOR PATIENTS RECEIVING ROCURONIUM AND SEVOFLURANE - OPTIMIZED REVERSAL WITHOUT TOF MONITORING VERSUS REVERSAL USING QUANTITATIVE TOF MONITORING: AN EQUIVALENCE STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035102

Enrollment

Registered

2018-12-01

Start date

2018-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubated patients under general anesthesia using sevoflurane and rocuronium

Interventions

For subjects in group A (without TOF monitoring), the first researcher counted the time since last rocuronium administration and assessed the subject&#39

s spontaneous breathing effort. Neostigmine dosing followed the protocol below: a. Neostigmine was administered if the spontaneous breathing has been detected or the time since last rocuronium admini

30 minutes, without evidence of spontaneous breathing effort: 50 mcg/kg and atropine sulfate 10 mcg/kg. Minimal spontaneous breathing, and the time since last rocuronium administration &lt

30 minutes: 30-40 mcg/kg and atropine sulfate 10 mcg/kg. Minimal spontaneous breathing, and the time since last rocuronium administration &gt

30 minutes: 20-30 mcg/kg and atropine sulfate 10 mcg/kg. Sufficient spontaneous breathing pattern: 10 mcg/kg and atropine sulfate 10 mcg/kg. Extubation was carried out in group A at least 15 minut

=0.40 (mild block): Neostigmine 40 mcg/kg and atropine sulfate 10 mcg/kg. TOF ratio 0.40-0.70 (minimal block): Neostigmine 20-30 mcg/kg and atropine sulfate 10 mcg/kg. TOF ratio 0.70-0.90 (minimal b

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients aged 18-60 years, with ASA 1-2 physical status who will undergo elective non-head/neck surgery below general anesthesia procedure intubation

Exclusion criteria

Exclusion criteria: elective surgery <1 hour duration; awake extubation or post-surgery intensive care admission; body mass index> 35 kg/m2; had hepatic disease (liver enzyme value> 50% normal value); renal insufficiency (serum creatinine>1.8 mg/dL), neuromuscular disease; consumption of drugs known to affect neuromuscular transmission; contraindications to neostigmine and or atropine sulfate; a history of hypersensitivity or allergic to neostigmine, rocuronium or anesthetic agent given; difficulty accessing the TOF measuring device in the ulnar nerve.

Design outcomes

Primary

Measure	Time frame
the proportion of subjects who have residual paralysis in the recovery room based on the threshold value <0.90	—

Secondary

Measure	Time frame
the proportion of subjects who have airway problems, respiration patterns, oxygen saturation, nausea and vomiting during 30 minutes in the recovery room	—

Countries

Asia(except Japan)

Contacts

Public ContactArdyan Prima Wardhana

FACULTY OF MEDICINE, GADJAH MADA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE THERAPY

ardyan.wardhana@yahoo.com6282138433032

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026