Three Different Doses of Neostigmine on the Reversal of Cisatracurium-induced Moderate Neuromuscular Blockade

NCT05037006 | Unknown Phase 4 DMC

• 1 other identifier: CAAE 50358321.5.0000.5373
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study will be to evaluate by means of a prospective randomized clinical trial, the time required for the reversal of moderate neuromuscular blockade (NMB) (Train-of-four count = 3; TOFc 3) to Train-of-four ratio (TOFr) \> 0.9 and TOFr = 1.0 after administration of different doses of neostigmine (30, 50 and 70 mcg/kg) in patients undergoing general anesthesia with propofol or sevoflurane. In addition, the probability of NMB reversal in less than 10 minutes or 15 minutes after neostigmine administration will be registered.

Conditions

Neuromuscular Blockade; Neuromuscular Blockade, Residual

Outcome Measures

Primary Outcomes (2)

• Reversal from TOFc 3 to TOFr 1.0

  Time required the appearance of the third response to TOF stimulation to complete NMB reversal

  Time from neostigmine administration up to 60 minutes

• Reversal from TOFc 3 to TOFr 0.9

  Time required the appearance of the third response to TOF stimulation to TOFr 0.9

  Time from neostigmine administration up to 60 minutes

Secondary Outcomes (2)

• Probability of complete NMB reversal in less than 10 minutes

  Time from neostigmine administration up to 60 minutes

• Probability of complete NMB reversal in less than 15 minutes

  Time from neostigmine administration up to 60 minutes

Study Arms (6)

Group I-30

EXPERIMENTAL

Inhalational anesthesia and reversal with neostigmine 30 mcg/kg and atropine 15 mcg/kg

Drug: Sevoflurane - Neostigmine 30

Group I-50

EXPERIMENTAL

Inhalational anesthesia and reversal with neostigmine 50 mcg/kg and atropine 25 mcg/kg

Drug: Sevoflurane - Neostigmine 50

Group I-70

EXPERIMENTAL

Inhalational anesthesia and reversal with neostigmine 70 mcg/kg and atropine 35 mcg/kg

Drug: Sevoflurane - Neostigmine 70

Group V-30

EXPERIMENTAL

Intravenous anesthesia and reversal with neostigmine 30 mcg/kg and atropine 15 mcg/kg

Drug: TIVA - Neostigmine 30

Group V-50

EXPERIMENTAL

Intravenous anesthesia and reversal with neostigmine 50 mcg/kg and atropine 25 mcg/kg

Drug: TIVA - Neostigmine 50

Group V-70

EXPERIMENTAL

Intravenous anesthesia and reversal with neostigmine 70 mcg/kg and atropine 35 mcg/kg

Drug: TIVA - Neostigmine 70

Interventions

Sevoflurane - Neostigmine 30 DRUG

Neostigmine 30 mcg/kg and atropine 15 mcg/kg when TOFc 3

Also known as: Inhalational anesthesia

Group I-30

Sevoflurane - Neostigmine 50 DRUG

Neostigmine 50 mcg/kg and atropine 25 mcg/kg when TOFc 3

Also known as: Inhalational anesthesia

Group I-50

Sevoflurane - Neostigmine 70 DRUG

Neostigmine 70 mcg/kg and atropine 35 mcg/kg when TOFc 3

Also known as: Inhalational anesthesia

Group I-70

TIVA - Neostigmine 30 DRUG

Neostigmine 30 mcg/kg and atropine 15 mcg/kg when TOFc 3

Also known as: TIVA

Group V-30

TIVA - Neostigmine 50 DRUG

Neostigmine 50 mcg/kg and atropine 25 mcg/kg when TOFc 3

Also known as: TIVA

Group V-50

TIVA - Neostigmine 70 DRUG

Neostigmine 70 mcg/kg and atropine 35 mcg/kg when TOFc 3

Also known as: TIVA

Group V-70

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients physical status according to the American Society of Anesthesiologists I and II
• submitted to nose or ear surgeries under general anesthesia

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidade Catolica de Sao Paulo: lead

Study Sites (1)

Santa Lucina Hospital

Sorocaba, São Paulo, 18030-230, Brazil

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

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

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, members of the nursing team, anesthesiologist involved in anesthesia or data collection will be aware of the dose of neostigmine to be administered. The type of anesthesia (inhalation or venous) will not be covered. An anesthesiologist not involved in the study will be responsible for preparing the solution containing neostigmine and atropine (diluted with saline solution until complete 20 mL) according to the group to which each patient belongs. Syringes (20 mL) 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, randomized, clinical trial

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: September 8, 2021
• Study Start: October 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)