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Evaluation of the Efficacy of Sugammadex Based on Ideal Body Weight of Obstetric Patients with Different Groups of Body Mass Indexes

Evaluation of the Efficacy of Sugammadex Based on Ideal Body Weight of Obstetric Patients with Different Groups of Body Mass Indexes for Reversal of Moderate Rocuronium-Induced Neuromuscular Blockade

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001633279
Acronym
SGX (Sugammadex)
Enrollment
90
Registered
2018-10-03
Start date
2018-11-05
Completion date
2018-12-20
Last updated
2019-01-28

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

Conditions

None listed

Brief summary

In this study, we aim to assess the effectiveness of intravenous 2 mg kg-1 sugammadex applied based on IBW of obstetric patients with three different groups of BMI for reversal of moderate rocuronium-induced neuromuscular blockade. The patients over 18 years old with ASA status II and scheduled for an elective caesarean section under general anesthesia will be enrolled to the study and then they will be allocated into three groups according to their BMI. The patients with BMI < 30 kg m-2 (normal BMI) will be allocated in group 1 (n=30), the patients with BMI between 30-40 kg m-2 (obese) in group 2 (n=30) and the patients with BMI > 40 kg m-2 (morbid obese) in group 3 (n=30). All patients will receive a standard anesthesia procedure. At the end of the surgery 2 mg kg-1 sugammadex based on ideal body weight of each patients will be applied. If needed, the patients will receive an additional sugammadex dose for successful extubation. We will compare mean sugammadex dose applied in each group for successful extubation, determine the duration between the first dose of sugammadex and successful extubation, motor response to commands and we will measure the duration between the end of surgery and first breast feding in different BMI groups.

Interventions

The patients included in the study will be allocated into three groups according to their BMI. The patients with BMI < 30 kg m-2 (normal BMI) will be allocated in group 1 (n=30), the patients with BMI between 30-40 kg m-2 (obese) in group 2 (n=30) and the patients with BMI > 40 kg m-2 (morbid obese) in group 3 (n=30). In the operating room, a standard monitorization including ECG, non-invasive blood pressure, pulse oxymeter, end-tidal CO2, Bi-spectral index (BIS) and train-of-four (TOF) will be

The patients included in the study will be allocated into three groups according to their BMI. The patients with BMI < 30 kg m-2 (normal BMI) will be allocated in group 1 (n=30), the patients with BMI between 30-40 kg m-2 (obese) in group 2 (n=30) and the patients with BMI > 40 kg m-2 (morbid obese) in group 3 (n=30). In the operating room, a standard monitorization including ECG, non-invasive blood pressure, pulse oxymeter, end-tidal CO2, Bi-spectral index (BIS) and train-of-four (TOF) will be performed to all patients by the anesthesiologist of the operating room. A 20 gauge intravenous line will be placed and each patient will receive 15 mL kg-1 hour-1 isotonic saline infusion. Ideal body weight (IBW) of each patient will be calculated according to the Devine formula (45.5 kg + 2.3 kg/2.4 cm over 152.4 cm) and all of the drugs will be applied based on the calculated IBW of each patient. After preoxygenation with 100% O2 for three minutes, the anesthesiologist will induce general anesthesia with intravenous 1.5-2 mg kg-1 propofol and 0.9 mg kg-1 rocuronium bromide. Endotracheal intubation will be performed when BIS score decreases below 60 and TOF score is below 10%. The anesthesiologist will maintain the anesthesia with 1-2.5% end-tidal sevofluran in a mixture of 40% O2-60% N2O by targeting a bi-spectral index (BIS) value between 40-60. Following delivery of baby by caesarian section, intravenous 4 mg ondansetron and intravenous 1 mcg kg-1 fentanyl will be applied to the mother. The fentanyl dose will be calculated according to the IBW of each patient again and 1 mcg kg-1 fentanyl will be administered. APGAR scores of newborns will be recorded at the first and fifth minute. All patients will receive intravenous 2 mg kg-1 tramadol for postoperative pain management at the end of the surgery. When train-of-four (TOF) value is 25% (moderate neuromuscular blockade), the anesthesiologist will apply intravenous 2 mg kg-1 sugammadex. TOF values will be measured at every 20 seconds intervals after sugammadex dose and if the measured TOF value is under 90% (T4/T1) at the end of 2 minutes, the patients will receive an additional dose of 2 mg kg-1 sugammadex. The time for TOF increased 90% will be recorded and then the patients will be extubated and transferred to Post anesthesia caring unit.

Sponsors

Basak ALTIPARMAK
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The patients over 18 years old with ASA status II and scheduled for an elective caesarean section under general anesthesia

Exclusion criteria

presence of pulmonary diseases (asthma, chronic obstructive pulmonary disease etc), known allergy to study drugs, use of medications that can affect neuromuscular blockade such as magnesium sulphate, anticonvulsive drugs, macrolids and aminoglycosides, decline participation to the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026