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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-10-31

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.

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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.

Conditions

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Anesthesia Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1 : (NS)

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

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type DRUG

half dose

Neostigmine

Intervention Type DRUG

IV = 50mcg/kg

glycopyrrolate

Intervention Type DRUG

Group 2 : (S)

patients receive Full recommended dose of sugammadex

Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB)

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type DRUG

full dose

Interventions

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Sugammadex

half dose

Intervention Type DRUG

Sugammadex

full dose

Intervention Type DRUG

Neostigmine

IV = 50mcg/kg

Intervention Type DRUG

glycopyrrolate

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes