Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dongsheng Zhang, MD, Yangzhou No.1 People's Hospital

ClinicalTrials.gov Identifier:

NCT02481193

First received: June 10, 2015

Last updated: June 22, 2015

Last verified: June 2015

History of Changes

Purpose

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

Condition	Intervention	Phase
Fasciculation	Drug: Cisatracurium	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Effects of Cisatracurium on Succinylcholine-induced Fasciculations and Myalgia

Resource links provided by NLM:

Drug Information available for: Succinylcholine chloride Cisatracurium besylate

U.S. FDA Resources

Further study details as provided by Dongsheng Zhang, MD, Yangzhou No.1 People's Hospital:

Primary Outcome Measures:

The presence of fasciculations [ Time Frame: After the injection of succinylcholine for 1.5 minutes ]

Secondary Outcome Measures:

Side effects of the pretreatment of cisatracurium [ Time Frame: At the time of three minutes after the pretreatment of cisatracurium ]
The time to maximal depression of twitch [ Time Frame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes ]
The extent to maximal depression of twitch [ Time Frame: 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 [ Time Frame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes ]
The grades of endotracheal intubation [ Time Frame: At intubating time ]
The changes of serum potassium [ Time Frame: After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation ]
Myalgia at 24 hours postoperatively [ Time Frame: At 24 hours postoperatively ]


Enrollment:	90
Study Start Date:	March 2013
Study Completion Date:	January 2014
Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cisatracurium 0.005 mg/kg The group received pretreatment of cisatracurium 0.005 mg/kg.	Drug: Cisatracurium Different doses of cisatracurium pretreatment Other Name: Dose
Experimental: Cisatracurium 0.01 mg/kg The group received pretreatment of cisatracurium 0.01 mg/kg	Drug: Cisatracurium Different doses of cisatracurium pretreatment Other Name: Dose
Experimental: Cisatracurium 0.02 mg/kg The group received pretreatment of cisatracurium 0.02 mg/kg	Drug: Cisatracurium Different doses of cisatracurium pretreatment Other Name: Dose

Detailed Description:

Purpose: To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations and postoperative myalgia.

Methods: Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized into three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium, respectively. General anesthesia was induced 3.5 min later, train of four stimulation was monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of fasciculations, intubating conditions, time and extent to maximal depression of twitch and time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively, serum potassium before the induction, at the time of endotracheal intubation, and 5 min after intubation were recorded.

Eligibility


Ages Eligible for Study:	20 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

American Standards Association (ASA) physical status I or II patients scheduled for elective laparoscopic cholecystectomies with tracheal intubation requiring general anesthesia
20 - 65 years old
without acid-base imbalance and electrolyte disturbance
with normal hepatic and renal function

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Dongsheng Zhang, MD, MD, Yangzhou No.1 People's Hospital
ClinicalTrials.gov Identifier:	NCT02481193 History of Changes
Other Study ID Numbers:	YZYY-610
Study First Received:	June 10, 2015
Last Updated:	June 22, 2015

Keywords provided by Dongsheng Zhang, MD, Yangzhou No.1 People's Hospital:


Cisatracurium Myalgia Fasciculation Succinylcholine

Additional relevant MeSH terms:


Fasciculation Myalgia Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Pain Neurologic Manifestations Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Neuromuscular Manifestations Cisatracurium Atracurium	Succinylcholine Neuromuscular Blocking Agents Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Neuromuscular Nondepolarizing Agents Nicotinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neuromuscular Depolarizing Agents

ClinicalTrials.gov processed this record on July 13, 2017

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