Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

NCT02481193 | Completed Phase 3 DMC

• 1 other identifier: YZYY-610
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.

Conditions

Fasciculation

Keywords

Cisatracurium; Myalgia; Fasciculation; Succinylcholine

Outcome Measures

Primary Outcomes (1)

• The presence of fasciculations

  After the injection of succinylcholine for 1.5 minutes

Secondary Outcomes (7)

• Side effects of the pretreatment of cisatracurium

  At the time of three minutes after the pretreatment of cisatracurium

• The time to maximal depression of twitch

  From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes

• The extent to maximal depression of twitch

  From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes

• The time for twitch recovery to 20% of its control value

  From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes

• The grades of endotracheal intubation

  At intubating time

Study Arms (3)

Cisatracurium 0.005 mg/kg

EXPERIMENTAL

The group received pretreatment of cisatracurium 0.005 mg/kg.

Drug: Cisatracurium

Cisatracurium 0.01 mg/kg

EXPERIMENTAL

The group received pretreatment of cisatracurium 0.01 mg/kg

Drug: Cisatracurium

Cisatracurium 0.02 mg/kg

EXPERIMENTAL

The group received pretreatment of cisatracurium 0.02 mg/kg

Drug: Cisatracurium

Interventions

Cisatracurium DRUG

Different doses of cisatracurium pretreatment

Also known as: Dose

Cisatracurium 0.005 mg/kg; Cisatracurium 0.01 mg/kg; Cisatracurium 0.02 mg/kg

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Standards Association (ASA) physical status I or II patients scheduled for elective laparoscopic cholecystectomies with tracheal intubation requiring general anesthesia
• years old
• without acid-base imbalance and electrolyte disturbance
• with normal hepatic and renal function

You may not qualify if:

• Patients with known hyperkalemia
• Patients with increased intraocular pressure
• Patients with increased intracranial pressure
• Patients with symptoms of gastroesophageal reflux
• Patients with anticipated airway difficulties
• Patients with malignant fever
• Patients with neuromuscular disease
• Patients with burn or crush injuries
• Patients with taking drugs known to alter the action of neuromuscular blockers
• Patients with with a body mass index exceeding 30

Sponsors & Collaborators

• Yangzhou No.1 People's Hospital: lead

MeSH Terms

Conditions

Fasciculation; Myalgia

Interventions

cisatracurium

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 25, 2015
• Study Start: March 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 25, 2015

Record last verified: 2015-06