Effects of Cisatracurium on Sccinylcholine-induced Fasciculations

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Zhuan Zhang, Yangzhou No.1 People's Hospital

ClinicalTrials.gov Identifier:

NCT02502032

First received: July 16, 2015

Last updated: October 8, 2015

Last verified: October 2015

History of Changes

Purpose

To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations.

Condition	Intervention	Phase
Fasciculations	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 Pretreatment With Different Doses of Cisatracurium on Succinylcholine-induced Fasciculations

Resource links provided by NLM:

Drug Information available for: Cisatracurium besylate

U.S. FDA Resources

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

Primary Outcome Measures:

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: From the time of 3 minutes after the pretreatment of cisatracurium for 0.5 minutes ]
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 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:	87
Study Start Date:	July 2015
Study Completion Date:	October 2015
Primary Completion Date:	October 2015 (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 groups received different pretreatments of cisatracurium. Other Name: Dose
Experimental: Cisatracurium 0.01 mg/kg The group received pretreatment of cisatracurium 0.01 mg/kg.	Drug: Cisatracurium Different groups received different pretreatments of cisatracurium. Other Name: Dose
Experimental: Cisatracurium 0.02 mg/kg The group received pretreatment of cisatracurium 0.02 mg/kg.	Drug: Cisatracurium Different groups received different pretreatments of cisatracurium. Other Name: Dose

Detailed Description:

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 cisatracurium pretreatments, at intubating time, 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 the contraindications associated with succinylcholine or cisatracurium;
Patients taking drugs known to alter the action of neuromuscular blockers;
Patients with a body mass index exceeding 30

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT02502032

Sponsors and Collaborators

Zhuan Zhang

Investigators


Study Director:	Xin-nong Liu, Professor	Yangzhou No. 1 Peoples' Hospital

More Information


Responsible Party:	Zhuan Zhang, MD, Yangzhou No.1 People's Hospital
ClinicalTrials.gov Identifier:	NCT02502032 History of Changes
Other Study ID Numbers:	ZZ0716
Study First Received:	July 16, 2015
Last Updated:	October 8, 2015

Additional relevant MeSH terms:


Fasciculation Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Cisatracurium Atracurium 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

ClinicalTrials.gov processed this record on July 13, 2017

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