Different Doses of Neostigmine for Reversal of Moderate Neuromuscular Blockade in Children

NCT05053594 | Unknown Phase 4

• 1 other identifier: CAAE 46436121.0.0000.5373
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is no recent information on the required dose of neostigmine for the reversal of cisatracurium-induced moderate neuromuscular blockade (NMB) \[Train-of-four (TOF) count = 1-3)\] in children. The aim of this study will be to evaluate by means of a prospective, randomized and double-blinded clinical trial, the time required for reversal of moderate NMB (TOFc 3) to T4/T1 (TOF ratio, TOFr) \> 0.9 and TOFr = 1.0 after administration of different doses of neostigmine (10, 20 or 30 mcg/kg) or placebo in children undergoing inhalational (sevoflurane) general anesthesia. In addition, the probability of NMB reversal in less than 10 minutes, the presence of bradycardia, respiratory complications and postoperative vomiting will be evaluated. The time for reversal is expected to be inversely proportional to the administered dose of neostigmine.

Conditions

Neuromuscular Blockade; Neuromuscular Block, Residual; Neuromuscular Block Prolonged

Outcome Measures

Primary Outcomes (1)

• Time for complete reversal of moderate NMB

  Time required for reversal of TOFc 3 to T4/T1 (TOF ratio, TOFr) = 1.0

  Time from neostigmine administration up 60 minutes after complete reversal

Secondary Outcomes (2)

• Time for reversal of moderate NMB to TOFr 0,9

  Time from neostigmine administration up to 60 minutes after complete reversal

• Probability of NMB reversal in less than 10 minutes

  Time from neostigmine administration up to 10 minutes

Study Arms (4)

Group N10

EXPERIMENTAL

Reversal with neostigmine 10 mcg/kg and atropine 5 mcg/kg

Drug: Neostigmine 10 mcg/kg

Group N20

EXPERIMENTAL

Reversal with neostigmine 20 mcg/kg and atropine 10 mcg/kg

Drug: Neostigmine 20 mcg/kg

Group N30

EXPERIMENTAL

Reversal with neostigmine 30 mcg/kg and atropine 15 mcg/kg

Drug: Neostigmine 30 mcg/kg

Group P

PLACEBO COMPARATOR

Spontaneous reversal (placebo)

Other: Placebo

Interventions

Neostigmine 10 mcg/kg DRUG

Once the third response to TOF is obtained, neostigmine 10 mcg/kg will be administered

Group N10

Neostigmine 20 mcg/kg DRUG

Once the third response to TOF is obtained, neostigmine 20 mcg/kg will be administered

Group N20

Neostigmine 30 mcg/kg DRUG

Once the third response to TOF is obtained, neostigmine 30 mcg/kg will be administered

Group N30

Placebo OTHER

Once the third response to TOF is obtained, saline will be administered

Group P

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children physical status according to the American Society of Anesthesiologists I and II
• Submitted to general anesthesia to perform tonsillectomy associated or not with adenoidectomy

You may not qualify if:

• Refusal to participate in the study
• Presence of kidney, liver or neuromuscular disease
• Contraindication to the use of any drug used in the study
• Body mass index (BMI) ≥ 30.

Sponsors & Collaborators

• Pontificia Universidade Catolica de Sao Paulo: lead

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Neostigmine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Eduardo T Moro, MD

  Pontificia Catholic University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo T Moro, MD

CONTACT

+5515997728015; edumoro85@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: For each patient, an opaque envelope will be prepared, sealed and numbered sequentially containing the group to which the patient will be allocated. A list of randomized computer-generated numbers (www.random.org) will be used for this purpose. No surgeon, assistant, nurse and anesthesiologist involved in anesthesia control or data collection will be aware of the dose of neostigmine to be administered. An anesthesiologist not involved in the study will be responsible for preparing the solution containing neostigmine and atropine (diluted with saline solution until complete 10mL) according to the group to which each patient belongs. The syringes will be similar and identified only with a label with the word "reversal".
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, controlled, randomized clinical trial

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: September 22, 2021
• Study Start: October 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 20, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From Clinical trials approval up to 12 months
• Access Criteria: If requested by email