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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: TCTR
Last refreshed on: 29 April 2024
Main ID:  TCTR20170328002
Date of registration: 28/03/2017
Prospective Registration: No
Primary sponsor: Faculty of Medicine, Prince of Songkhla University
Public title: The effect of nicardipine on the onset time and intubating conditions of cisatracurium
Scientific title: The effect of nicardipine on the onset time and intubating conditions of cisatracurium
Date of first enrolment: 27/03/2017
Target sample size: 99
Recruitment status: Pending (Not yet recruiting)
URL:  https://www.thaiclinicaltrials.org/show/TCTR20170328002
Study type:  Interventional
Study design:  Randomized  
Phase:  Phase 2
Countries of recruitment
Thailand
Contacts
Name: Sahawat    Thertchanakun
Address:  Hat Yai 90110 Songkhla Thailand
Telephone: 0869626827
Email: sahawatt@gmail.com
Affiliation:  Department of Anesthesiology, Faculty of Medicine, Prince of Songkhla University
Name: Sahawat    Thertchanakun
Address:  Hat Yai 90110 Songkhla Thailand
Telephone: 0869626827
Email: sahawatt@gmail.com
Affiliation:  Department of Anesthesiology, Faculty of Medicine, Prince of Songkhla University
Key inclusion & exclusion criteria
Inclusion criteria: - The patients receiving an elective surgery, which general anesthesia with endotracheal intubation is needed
- American Society of Anesthesiologists (ASA) Physical Status 1-2
- Normal Blood Pressure

Exclusion criteria: - The patients with Cardiac underlying diseases
- The patients with a history of Niicardipine or Cisatracurium allergy
- The pateints with a history of Malignant Hyperthemia
- The patients with a history of Neuromuscular disease
- The patients currently on cardiac pacemaker
- The pregnant patients
- The patients who are morbidly obese, defining as BMI of at least 35 kg per square meter
- The patients who are unable to communicate to give necessary information


Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Intubation
Onset time of Cisatracurium
Nicardipine
Intubating condition
Grade of intubation
Hemodynamic response after intubation
Onset time of Cisatracurium
Nicardipine
Intubating condition
Grade of intubation
Hemodynamic response after intubation
Intervention(s)
Normal Saline 10 ml before induction agent,Nicardipine 10 mcg/kg + Normal Saline up to 10 ml,Nicardipine 20 mcg/kg + Normal Saline up to 10 ml
Placebo Comparator Drug,Experimental Drug,Experimental Drug
Normal Saline,Nicardipine 10 mcg/kg,Nicardipine 20 mcg/kg
Primary Outcome(s)
Effect of Nicardipine on Onset time of Cisatracurium After the Cisatracurium injection time, until maximal depression (TOF = 0) Duration since the Cisatracurium injection time to maximal depression (TOF = 0)
Secondary Outcome(s)
Grade of intubation After Intubation Intubation grade assessed by the intubating personnel,Intubating condition After intubation Intubating condition assessed by the intubating personnel,Hemodynamic response to intubation Every 1 minute until 5 minutes after intubation Blood Pressure, Heart Rate every 1 minute until 5 minutes after intubation
Secondary ID(s)
Source(s) of Monetary Support
Faculty of Medicine, Prince of Songkhla University
Secondary Sponsor(s)
Faculty of Medicine, Prince of Songkhla University
Ethics review
Status: Submitted, approved
Approval date:
Contact:
medpsu.ec@gmail.com
Office of Human Research Ethics Committee (HREC), Faculty of Medicine, Prince of Songkhla University
074451149 Ext. 1157
medpsu.ec@gmail.com
Results
Results available:
Date Posted:
Date Completed: 30/09/2017
URL:
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