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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anesthesia Recovery

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Sugammadex
* Drug: Neostigmine
* Drug: glycopyrrolate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 : (NS)<br>Group 1 Drug combination: patients receive half of the recommended dose of sugammadex plus dose of neostigmine Sugammadex IV= -1 mg/kg( moderate NMB) or 2 mg/kg (deep NMB) neostigmine IV = 50mcg/kg glycopyrrolate 10 mcg/kg | Drug: Sugammadex<br>* half dose<br>Drug: Neostigmine<br>* IV = 50mcg/kg<br>Drug: glycopyrrolate<br> <br> |
| Active Comparator: Group 2 : (S)<br>patients receive Full recommended dose of sugammadex Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB) | Drug: Sugammadex<br>* full dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOF ratio of 0.9 |  | within 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to return of TOF ratio to 0.9 and the time till extubation |  | within 10 minutes | 
| Residual neuro-muscular blockade | Post Anesthesia recovery unit | within 10 to 180 mins |