Reversal of Moderate or Superficial Neuromuscular Blockade Induced by Cisatracurium

NCT04920682 | Completed Phase 4 DMC

• 1 other identifier: CAAE 39680120.7.0000.5373
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The administration of acetylcholinesterase inhibiting agents (such as neostigmine) has been used to reverse the muscle paralysis induced by non-depolarizing neuromuscular blocking agents. It is not well known whether there is a difference between the time required for complete reversion of moderate neuromuscular blockade (NMB) after the administration of neostigmine in usual doses when compared to the reversion of superficial NMB with the use of a reduced dose of the same agent (excessive doses of neostigmine administered during superficial blocks may cause paradoxical muscle weakness). The aim of the present study will be to compare, by means of a prospective, randomized, controlled and double-blind clinical trial, the times necessary for the reversion of moderate block with neostigmine 60 mcg / kg or for superficial block to reach values of T4 / T1\> 0.9 using neostigmine 30 mcg / kg.

Conditions

Neostigmine; Neuromuscular Blocking Agents; Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• Time necessary for the reversal of moderate blockade using neostigmine 60 mcg / kg or for reversal of superficial blockade using neostigmine 30 mcg / kg

  Time necessary for the reversion of TOF = 3 (moderate block) to T4 / T1 values 1.0 (with neostigmine 60 mcg / kg) or for T4 / T1\> 0.4 (superficial block) to reach values of T4 / T1\> 1.0 (with neostigmine 30 mcg / kg)

  Time from cisatracurium administration until T4 / T1 ratio reaches a value equal to 1.0 assessed up to 2 hours

Secondary Outcomes (1)

• Probability of reversing the NMB in less than 10 minutes

  Time from TOF=3 until T4 / T1 ratio reaches a value equal to 1.0 assessed up to 2 hours

Study Arms (4)

Group M (reversion with moderate neuromuscular blockade)

ACTIVE COMPARATOR

Administration of neostigmine 60 mcg/kg and atropine 30 mcg/kg when TOF (Train-of-Four) = 3 and saline when TOF (T4 / T1)\> 0.4.

Drug: Reversal of moderate neuromuscular blockade

Group S (reversion with superficial moderate neuromuscular blockade)

ACTIVE COMPARATOR

Administration of 0.9% saline solution (SF) when TOF = 3 and neostigmine 30 mcg/kg and atropine 15 mcg/kg when TOF (T4 / T1)\> 0.4.

Drug: Reversal of superficial neuromuscular blockade

Group N (two-step reversal of neuromuscular blockade)

ACTIVE COMPARATOR

Administration of neostigmine 30 mcg/kg and atropine 15 mcg/kg when TOF = 3 and neostigmine 30 mcg/kg and atropine 15 mcg/kg when TOF (T4 / T1)\> 0.4 .

Drug: Two-step reversal

Group P (placebo)

PLACEBO COMPARATOR

Administration of 0.9% saline solution (SF) when TOF = 3 and when TOF (T4 / T1)\> 0.4.

Drug: Placebo

Interventions

Reversal of moderate neuromuscular blockade DRUG

Neostigmine 60 mcg/kg when TOF (Train-of-Four) = 3 and saline when TOF (T4 / T1)\> 0.4

Group M (reversion with moderate neuromuscular blockade)

Reversal of superficial neuromuscular blockade DRUG

Neostigmine 30 mcg/kg when TOF (T4 / T1)\> 0.4

Group S (reversion with superficial moderate neuromuscular blockade)

Two-step reversal DRUG

Neostigmine 30 mcg/kg when TOF = 3 and neostigmine 30 mcg/kg when TOF (T4 / T1)\> 0.4

Group N (two-step reversal of neuromuscular blockade)

Placebo DRUG

0.9% saline solution (SF) when TOF = 3 and when TOF (T4 / T1)\> 0.4

Group P (placebo)

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 aged between 18 and 65 years
• Undergoing general anesthesia for nose and ear surgery
• Physical status according to the American Society of Anesthesiologists I and II

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

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Eduardo T Moro, MD

  Pontificia Catholic University of São Paulo

  PRINCIPAL INVESTIGATOR

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 random numbers generated by computer (www.random.org), in blocks of 1: 1: 1: 1, will be used for this purpose. No collaborator in the operating room, surgeon or anesthesiologist involved in the control of anesthesia and data collection will be aware of the content of the solutions (neostigmine with atropine or saline). An anesthesiologist not involved in the study will be responsible for preparing the solutions: * solution 1 (administered when TOF = 3) - neostigmine 60 mcg/kg and atropine 30 mcg/kg diluted with SF until 20 mL (group M); neostigmine 30 mcg/kg and atropine 15 mcg/kg diluted with SF to 20 mL (group N) or 0.9% SF 20 mL (group S) * solution 2 (administered when T4 / T1\> 0.4) - neostigmine 30 mcg/kg and atropine 15 mcg/kg diluted with SF until 20 mL (group M or N) or SF 0.9% 20 mL (group S)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, randomized, controlled and double-blind clinical trial

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: June 10, 2021
• Study Start: June 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 21, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

BR (1)