"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"

American University of Beirut Medical Center

Status and phase: Completed; Phase 4

Conditions: Anesthesia Recovery

Treatments: Drug: glycopyrrolate; Drug: Sugammadex; Drug: Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT02375217

ANES.MA.14

Details and patient eligibility

About

Prospective Randomized non inferiority Trial involving adult patients undergoing elective surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose sugammadex vs half dose sugammadex for reversal of NMB.

Full description

The investigators' aim is to prove that half dose sugammadex in combination with neostigmine 0.05 mg/kg is non-inferior to the recommended dose of sugammadex for the reversal of deep ( absence of Trian of Four response :TOF) or moderate ( TOF 1 or 2 twiches) muscle paralysis in patients undergoing surgery under general anesthesia.

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged 18-70
• ASA class I, II, and III
• undergoing surgery under balanced general anesthesia requiring the use of muscle relaxants throughout the surgery

Exclusion criteria

• patients undergoing emergency surgeries
• pregnant patients
• patients with end stage renal disease or chronic kidney disease(GFR less than 60)
• patients with allergy to sugammadex or who had previous complications or side effects from previous sugammadex administration
• patients' refusal
• patients with allergy to recuronium

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Group 1 : (NS)

Active Comparator group

Description:

Group 1 Drug combination: patients receive half of the recommended dose of sugammadex plus dose of neostigmine" 1. Sugammadex IV= -1 mg/kg( moderate NMB) or * 2 mg/kg (deep NMB) 2. neostigmine IV = 50mcg/kg 3. glycopyrrolate 10 mcg/kg

Treatment:

Drug: Neostigmine

Drug: glycopyrrolate

Drug: Sugammadex

Drug: Sugammadex

Group 2 : (S)

Active Comparator group

Description:

patients receive Full recommended dose of sugammadex Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB)

Treatment:

Drug: Sugammadex

Drug: Sugammadex