Comparing Reversal With Neostigmine and Sugammadex in Paediatric

NCT03137290 | Completed DMC

• 1 other identifier: JEPeM/281.3(3)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A reversal agent is commonly given to improve neuromuscular function after intra-operative administration of non-depolarizing neuromuscular blocking agents. The administration of conventional reversal agent neostigmine is associated with many undesirable side effects. For almost a decade, a new novel drug sugammadex has been used to specifically antagonize the effect of aminosteroidal neuromuscular blocking agents. A total of 80 paediatric patients planned for general anaesthesia were divided into two groups and were given either neostigmine+atropine, or sugammadex for reversal once the operation had completed.

Conditions

Neuromuscular Blockade

Keywords

Paediatric general anaesthesia; Rocuronium; Neostigmine; Sugammadex

Outcome Measures

Primary Outcomes (1)

• Recovery time

  To assess the recovery time from TOF count of 2 or 3 to TOF ratio of more than 0.9 between neostigmine or sugammadex in reversal of rocuronium induced neuromuscular blockade in paediatric patients.

  From the time the reversal drugs (neostigmine or sugammadex) were given at TOF count of 2-3 till the TOF ratio is more than 0.9 up to 5 minutes after the operation finished

Secondary Outcomes (6)

• Adequate ventilation

  From the time of the reversal drugs (neostigmine or sugammadex) were given till patient achieved good ventilation (tidal volume 6 ml/kg) up to 5 minutes after the operation finished

• Extubation time

  From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is extubated up to 5 minutes after the operation finished.

• Blood Pressure

  From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes.

• Heart Rate

  From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes.

• Oxygen saturation

  From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes.

Study Arms (2)

Neostigmine

ACTIVE COMPARATOR

1 mg of Atropine (1ml) was mixed with 2.5mg of Neostigmine (1ml) and diluted into 10mls with Normal Saline 0.9% in a 10ml standard syringe.

Drug: Neostigmine

Sugammadex sodium

EXPERIMENTAL

100mg Sugammadex (1ml) is diluted into 10mls in a standard 10mls syringe with Normal Saline 0.9%.

Drug: Sugammadex Sodium

Interventions

Neostigmine DRUG

The TOF Watch Sx, and Paediatric Bispectral Index (BIS) monitoring were put on patient. Gaseous induction, with oxygen and Sevoflurane was given until BIS was 40-50, then a intravenous line was obtained. 2 mcg/kg of fentanyl was given for analgesia. then,the TOF Watch Sx was calibrated.The patient was paralyzed with 0.6mg/kg of rocuronium, and intubation of the trachea was done once TOF count was less than 1. A maintenance of 0.2 mg/kg of Rocuronium was given boluses every 30 minutes to maintain TOF count between 2-3. At the end of surgery, TOF count was checked to ensure it was between 2-3. Then a reversal dose for TOF count of 2 to 3 was 0.05 mg/kg of Neostigmine with 0.02 mg/kg of Atropine. Therefore the volume would be 0.2 mls per kg is to be administered.

Also known as: Prostigmine

Neostigmine

Sugammadex Sodium DRUG

The TOF Watch Sx, and Paediatric Bispectral Index (BIS) monitoring were put on patient. Gaseous induction, with oxygen and Sevoflurane was given until BIS was 40-50, then a intravenous line was obtained. 2 mcg/kg of fentanyl was given for analgesia. then,the TOF was calibrated.The patient was paralyzed with 0.6mg/kg of rocuronium, and intubation of the trachea was done once TOF count was less than 1. A maintenance of 0.2 mg/kg of Rocuronium was given boluses every 30 minutes to maintain TOF count between 2-3. At the end of surgery, TOF count was checked to ensure it between 2-3. Then the dose for reversal of sugammadex with a TOF count of 2 or 3 would be 2 mg/kg. This will also be equivalent to a volume of 0.2 mls per kg and given at the end of surgery.

Also known as: Bridion

Sugammadex sodium

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anaesthesiologist (ASA) physical status 1 and 2.
• Paediatric patients within the above criteria whom require rocuronium induced neuromuscular blockage for general anaesthesia

You may not qualify if:

• Active or recent upper respiratory tract infection (within 2 weeks)
• Haemodynamically unstable patients for example trauma, haemorrhage, sepsis, thyrotoxic or cardiac failure
• Patients with pre-existing neuromuscular disorders
• Patients with renal failure, with creatinine clearance of less than 30mmol/L
• Patients requiring post-operative ventilation
• Patients with known allergy to sugammadex or neostigmine

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

University of Science Malaysia Hospital

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (4)

• Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. Eur J Anaesthesiol. 2010 Oct;27(10):874-81. doi: 10.1097/EJA.0b013e32833d56b7.

  PMID: 20683334 RESULT

• Khuenl-Brady KS, Wattwil M, Vanacker BF, Lora-Tamayo JI, Rietbergen H, Alvarez-Gomez JA. Sugammadex provides faster reversal of vecuronium-induced neuromuscular blockade compared with neostigmine: a multicenter, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):64-73. doi: 10.1213/ane.0b013e3181ac53c3. Epub 2009 Aug 27.

  PMID: 19713265 RESULT

• Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.

  PMID: 19194156 RESULT

• Sacan O, White PF, Tufanogullari B, Klein K. Sugammadex reversal of rocuronium-induced neuromuscular blockade: a comparison with neostigmine-glycopyrrolate and edrophonium-atropine. Anesth Analg. 2007 Mar;104(3):569-74. doi: 10.1213/01.ane.0000248224.42707.48.

  PMID: 17312210 RESULT

MeSH Terms

Interventions

Neostigmine; Sugammadex

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Rhendra Hardy Mohamad Zaini, MD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: May 2, 2017
• Study Start: December 1, 2014
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)