|
Main
|
|
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:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03058263 |
|
Date of registration:
|
12/02/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Neostigmine on the Recovery of Rocuronium: A Comparison Between Partial and TOF Ratio-Based Dose
|
|
Scientific title:
|
The Effectiveness of Neostigmine on the Recovery of Rocuronium-Induced Neuromuscular Blockade: A Comparison Between Partial Dose and TOF Ratio-Based Adjustment Dose |
|
Date of first enrolment:
|
October 2016 |
|
Target sample size:
|
66 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03058263 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
Indonesia
| | | | | | | |
|
Contacts
|
|
Name:
|
Arif HM Marsaban, Consultant |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Indonesia University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- patients aged 18-60 years old
- American Society of Anesthesiologists (ASA) physical status I-II who were planned to
undergo any elective surgery at operating room in general anesthesia
- subjects had been explained about the study, and agreed to enroll and have signed the
informed consent form
Exclusion Criteria:
- BMI = 30
- had any severe kidney or liver disease
- had neuromuscular disease or asthma
Drop out Criteria:
- Duration of operation less than one hour or more than 2 hours
- during surgery received maintenance dose of neuromuscular block
- intraoperative cardiac arrest was occurred
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
General Anesthesia
|
|
Muscle Relaxant
|
|
Intervention(s)
|
|
Drug: Dose of Neostigmine
|
|
Primary Outcome(s)
|
|
time needed to reach TOF ratio = 90% in group with partial dose of neostigmine
[Time Frame: Day 1]
|
|
TOF ratio between partial dose of neostigmine and TOF ratio-based dose of neostigmine
[Time Frame: Day 1]
|
|
TOF ratio with TOF ratio-based dose of neostigmine
[Time Frame: Day 1]
|
|
TOF ratio with partial dose of neostigmine
[Time Frame: Day 1]
|
|
Secondary ID(s)
|
|
IndonesiaUAnes011
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|