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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02673723 |
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Date of registration:
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23/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation
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Scientific title:
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The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation-a Multiple Center, Randomized, Controlled,Double Blinded Clinical Trial |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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520 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02673723 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Wei Er Gu, PhD,MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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First affiliated Hospital of Anhui Medical University Locations: China, |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Written informed consent;
2. Selective surgery and general anesthesia patients;
3. Age 18-65 yrs;
4. Anesthesia Society of American (ASA) Scale I~II;
Exclusion Criteria:
1. Mallampatis ?-?;
2. Heat rate < 50 beats/minutes;
3. II-III Atrioventricular block;
4. Use of alpha agonist or antagonist within two weeks;
5. Use of opioid within 24 hours;
6. Serious heart, liver, kidney disease and cerebrovascular disease;
7. Allergic to the trial drug and other anesthesia drug contraindication;
8. Factors existed that affect language communication;
9. Any respiratory disease;
10. Unsuccessful intubation for 3 times or drop out during intubation.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Awake Tracheal Intubation
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Intervention(s)
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Drug: Saline
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Drug: Docozine
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Primary Outcome(s)
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The variation of pulse oxygen saturation
[Time Frame: anesthesia induction]
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The occurrence of cough response
[Time Frame: anesthesia induction]
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The variation of blood pressure
[Time Frame: anesthesia induction]
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Sedation assessment
[Time Frame: anesthesia induction]
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The variation of heart rate
[Time Frame: anesthesia induction]
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Secondary Outcome(s)
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The occurrence of cardiovascular events
[Time Frame: from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery]
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The occurrence of treatment-related adverse events
[Time Frame: from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery]
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Secondary ID(s)
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FirstHAnhuiMU
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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