Effects of Cisatracurium on Sccinylcholine-induced Fasciculations

NCT02502032 | Completed Phase 3 DMC

• 1 other identifier: ZZ0716
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fasciculations

Outcome Measures

Primary Outcomes (1)

• Presence of fasciculations

  After the injection of succinylcholine for 1.5 minutes

Secondary Outcomes (6)

• Side effects of the pretreatment of cisatracurium

  From the time of 3 minutes after the pretreatment of cisatracurium for 0.5 minutes

• 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 grades of endotracheal intubation

  At intubating time

• The changes of serum potassium

  After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation

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 groups received different pretreatments of cisatracurium.

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 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

Sponsors & Collaborators

• Zhuan Zhang: lead

MeSH Terms

Conditions

Fasciculation

Interventions

cisatracurium

Condition Hierarchy (Ancestors)

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

Study Officials

• Xin-nong Liu, Professor

  Yangzhou No. 1 Peoples' Hospital

  STUDY DIRECTOR

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: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 17, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10