Trial Outcomes & Findings for Sugammadex ED90 Dose in the Obese Patients (NCT NCT02568345)

NCT ID: NCT02568345

Last Updated: 2016-02-22

Results Overview

Complete reversal of neuromuscular blockade occured when the patient had a TOF T4/T1 ≥ 0.9 within eight minutes of sugammadex infusion. The sequencial design method of up-and-down was applied to determine the minimum effective dose in 90% of patients (ED90). An effective dose is one that achieves complete reversal of neuromuscular blockade that is defined as a measure of TOF equal or higher than 0.9, or a relationship between T4 an T1 measure ≥ 0.9, within eight minutes of sugammadex infusion.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: 8 minutes
• Results posted on: 2016-02-22

Participant Flow

Participant milestones

Measure	Sugammadex ED90 Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90). The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg. sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg. In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg.
Overall Study STARTED	31
Overall Study Treated at 2.2 mg/kg	3
Overall Study Treated at 2.4 mg/kg	25
Overall Study Treated at 2.6 mg/kg	3
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sugammadex ED90 Dose in the Obese Patients

Baseline characteristics by cohort

Measure	Sugammadex ED90 n=31 Participants Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90). The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg. sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg. In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Brazil	31 participants n=5 Participants
body mass index: kg.m^2	49.3 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 8 minutes

Complete reversal of neuromuscular blockade occured when the patient had a TOF T4/T1 ≥ 0.9 within eight minutes of sugammadex infusion.

The sequencial design method of up-and-down was applied to determine the minimum effective dose in 90% of patients (ED90). An effective dose is one that achieves complete reversal of neuromuscular blockade that is defined as a measure of TOF equal or higher than 0.9, or a relationship between T4 an T1 measure ≥ 0.9, within eight minutes of sugammadex infusion.

Outcome measures

Measure

Sugammadex ED90 n=31 Participants Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90). The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg. sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg. In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg.

Sugammadex ED90

2.40 mg/kg Interval 2.2 to 2.6

Adverse Events

Sugammadex ED90

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mauro Prado da Silva

Central Hospital, Irmandade da Santa Casa de Misericórdia (ISCM)

Phone: +55 11 2176 7000

Email: comissaocientifica@fcmsantacasasp.edu.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place