To compare sugammadex and neostigmine for reversal of rocuronium-induced neuromuscular blockade under general anaesthesia.

Data were collected from adult patients admitted to Chamarajanagar Institute of Medical Sciences, Chamarajanagar, who were scheduled for elective ENT surgery under general anaesthesia.

The study was conducted as a prospective, randomised, double-blinded comparative study.

The study was conducted in the Department of Anaesthesiology, Chamarajanagar Institute of Medical Sciences Hospital, Chamarajanagar, Karnataka.

The study was conducted over 18 months, from June 2024 to December 2025.

The calculated minimum was approximately 27 patients per group. After allowing for a 10% dropout rate, the target was rounded to 30 patients per group. Thus, 60 patients were enrolled, with 30 in each group.

Patients were included if they:

Patients were excluded if they had:

After institutional ethics committee approval, eligible patients were assessed during the pre-anaesthetic evaluation. The study procedures, potential risks, and expected benefits were explained, and written informed consent was obtained before enrolment.

Participants were assigned by computer-generated random numbers to one of two groups:

An anaesthesiologist who was not involved in the study prepared the reversal drug. Both preparations were diluted to 10 mL to maintain blinding of the participant and the investigator conducting the assessment.

On arrival in the preoperative area, standard monitoring with electrocardiography, pulse oximetry, and non-invasive blood pressure was applied. An 18-gauge intravenous cannula was inserted, and Ringer’s lactate was administered. Anaesthesia was induced and maintained according to the institutional protocol. Premedication included glycopyrrolate, ondansetron, dexamethasone, and midazolam; lidocaine was administered before induction, followed by propofol and fentanyl. Rocuronium 0.6 mg/kg was administered for tracheal intubation, with supplemental doses of 0.1 mg/kg given when indicated by neuromuscular monitoring.

Neuromuscular function was monitored with an acceleromyographic GE Datex-Ohmeda E-NMT module. Surface electrodes were placed over the ulnar nerve near the wrist, and the forearm was immobilised. Train-of-four stimulation was applied at 15-second intervals, and the evoked response of the adductor pollicis muscle was monitored during surgery.

At the end of surgery, when no further neuromuscular blockade was required, patients were allowed to recover until the second twitch (T2) reappeared. The allocated reversal drug was then administered intravenously. TOF monitoring continued until the TOF ratio reached at least 0.9; the interval from reversal-drug administration to this threshold was recorded.

Consciousness and clinical recovery were assessed. In conscious, cooperative patients, a five-second head-lift test, handgrip, arm lift, and eye opening were assessed. Patients who had recovered and were haemodynamically stable were extubated. Heart rate and blood pressure were recorded before reversal and at 5, 10, 15, 30, 60, and 120 minutes after administration. After extubation, oxygen saturation, respiratory rate, and heart rate were monitored in the recovery room for at least 60 minutes. Patients were observed for signs of recurrent blockade, including respiratory-rate changes or oxygen saturation below 90%. A further clinical assessment of neuromuscular recovery and respiratory adequacy was performed at least 10 hours after study-drug administration.

The time to achieve an Aldrete score of at least 9, extubation time, haemodynamic measurements, and adverse events including bradycardia and postoperative nausea and vomiting were also recorded.

No biological samples were collected or processed. Patient and perioperative data were recorded in a structured proforma and entered into a master chart. Data were checked for completeness and coded before statistical analysis. Continuous outcomes included time to TOF ratio ≥0.9, extubation time, time to Aldrete score ≥9, and haemodynamic measurements. Categorical outcomes included ASA class, clinical recovery findings, and adverse events.

Data were entered in Microsoft Excel 2019 and analysed using Epi Info version 7.2.6. Continuous variables were summarised using mean and standard deviation when normally distributed; medians were used for skewed data. Categorical variables were presented as frequencies and percentages.

The independent-samples t test was used to compare normally distributed continuous outcomes between groups. The Mann–Whitney U test was used for skewed continuous outcomes. Categorical variables were compared using the chi-square test or Fisher’s exact test when expected cell counts were small. A two-sided p value below 0.05 was considered statistically significant.

Clinical Trials Registry of India registration number: CTRI/2025/03/082137.

The sugammadex and neostigmine groups were similar in age, sex, height, weight, BMI, and ASA physical status; none of the between-group comparisons was statistically significant (all p > 0.05). This balance supports the comparability of the groups, although nonsignificant tests do not establish that the groups were identical. The results apply most directly to this relatively young, low-risk study population. Trials involving older or higher-risk patients, such as those by Togioka et al. (2020) and Ledowski et al. (2021), studied a different population and assessed additional outcomes such as postoperative pulmonary complications.

Recovery to a TOF ratio of at least 0.9 was faster with sugammadex than with neostigmine in this study: 2.9 versus 9.1 minutes, a mean difference of −6.2 minutes. This is consistent with the direction of effect reported in comparative reviews. Hristovska et al. (2017) and Hristovska et al. (2018) found substantially faster recovery with sugammadex in adults; in their pooled analysis of moderate block, recovery took approximately 2.0 minutes with sugammadex and 12.9 minutes with neostigmine. These pooled estimates are not directly interchangeable with the present results because reversal time depends on block depth, dose, monitoring method, and study protocol.

The early recovery pattern in the present study was also pronounced: 70.0% of patients in the sugammadex group reached TOF ≥0.9 within 3 minutes, compared with 6.7% in the neostigmine group. Kaufhold et al. (2016) similarly found that neostigmine did not reliably reverse residual block to a TOF ratio of 0.9 within 10 minutes in their dose-finding study. In randomised studies, Moon et al. (2020) and Farag et al. (2021) also reported faster neuromuscular recovery with sugammadex. Farag et al. (2021), however, did not find that the faster reversal necessarily produced a significant difference in extubation time in their neurointerventional setting.

The shorter extubation time and time to Aldrete score ≥9 in the present study are consistent with earlier recovery milestones, but they should not be interpreted as proof of shorter PACU stay or better longer-term recovery. In the DATA trial, Piccioni et al. (2024) found faster recovery to TOF ≥0.9 and earlier extubation with sugammadex, but no significant difference in PACU stay or hospital length of stay. A randomised trial in patients with obstructive sleep apnoea undergoing bariatric surgery likewise found no difference in operating-room discharge time or postoperative complications (Ajetunmobi et al., 2025).

The present results do not show a consistent haemodynamic difference across all measurement times. There were isolated nominal differences in heart rate and diastolic blood pressure, while systolic blood pressure did not differ significantly at any time point. Because these were separate, unadjusted comparisons across multiple time points, the isolated p values should be interpreted cautiously: some may reflect chance findings. Tsai et al. (2023) reported more stable haemodynamic changes with sugammadex in neurointerventional anaesthesia, but their procedure, patient context, and use of accompanying medication differ from this study. The present table therefore supports a cautious conclusion of no clear, sustained haemodynamic advantage.

Bradycardia and postoperative nausea and vomiting were numerically less frequent with sugammadex, but neither individual comparison was statistically significant. With only 30 participants per group, the study had limited ability to detect differences in relatively uncommon events. Hsieh et al. (2023), in a meta-analysis of 40 randomised trials, reported a modestly lower risk of postoperative nausea and vomiting with sugammadex; however, evidence on individual adverse effects has varied across reviews and trials. The 2023 American Society of Anesthesiologists guideline (Thilen et al., 2023) emphasises quantitative monitoring and adequate recovery before extubation, while the comparative evidence for specific adverse effects remains less definitive than the evidence for faster reversal.

The composite adverse-event rate was lower with sugammadex (13.3% versus 40.0%, p = 0.020). This finding is worth reporting, but it should be interpreted in light of the small number of events and the composite outcome. Broader clinical-outcome studies have not been fully consistent: some observational analyses reported fewer pulmonary complications with sugammadex (Kheterpal et al., 2020; Colquhoun et al., 2023), while randomised or other cohort studies have reported no clear difference (Togioka et al., 2020; Olesnicky et al., 2022; Ren et al., 2024). Olesnicky et al. (2024) reviewed patient morbidity and recovery outcomes and highlighted uncertainty in translating faster neuromuscular reversal into consistent improvements in broader postoperative outcomes. This study itself was too small and narrow in scope to determine whether either drug changes the risk of rare or serious postoperative complications.