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The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673723
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Xinqi Cheng, The First Affiliated Hospital of Anhui Medical University

Brief Summary:

Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to find a safe and effective method for intubation. Awake tracheal intubation which is used to retain spontaneous breathing is one of the important measures to ensure the safety of the patients with difficult airway in anesthesia.

Sufentanil is used to provide good analgesia and can effectively inhibit the reaction of awake tracheal intubation, however, the outstanding problem is serious respiratory depression after intravenous sufentanil injection. Few study showed that dezocine is a kappa opioid antagonist related to mild respiratory depression and can prevents sufentanil-induced cough during general anesthesia induction.It is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dezocine prevents sufentanil-induced respiratory depression and whether dezocine combined sufentanil is a safe and effective method for awake tracheal intubation.


Condition or disease Intervention/treatment Phase
Awake Tracheal Intubation Drug: Docozine Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation-a Multiple Center, Randomized, Controlled,Double Blinded Clinical Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Dezocine
Dezocine(Dez A:0.05 mg/kg,Dez B:0.1 mg/kg and Dez C:0.15 mg/kg, diluted to 5 ml respectively) is given for 10 seconds after surface anesthesia
Drug: Docozine
dezocine(Dez A:0.05 mg/kg,Dez B:0.1 mg/kg and Dez C:0.15 mg/kg, diluted to 5 ml respectively) is given for 10 seconds after surface anesthesia

Placebo Comparator: Controlled
The same amount of saline is given for 10 seconds after surface anesthesia
Drug: Saline
The same amount of saline is given for 10 seconds after surface anesthesia




Primary Outcome Measures :
  1. Sedation assessment [ Time Frame: anesthesia induction ]
    Observer's assessment of alertness/sedation(OAA/S) scale is used to assess the depth of sedation during anesthesia induction

  2. The occurrence of cough response [ Time Frame: anesthesia induction ]
    The cough scale is used to assess cough response the during anesthesia induction

  3. The variation of blood pressure [ Time Frame: anesthesia induction ]
    The variation of blood pressure(mmHg) during anesthesia induction

  4. The variation of heart rate [ Time Frame: anesthesia induction ]
    The variation of heart rate(bpm)during anesthesia induction

  5. The variation of pulse oxygen saturation [ Time Frame: anesthesia induction ]
    The variation of pulse oxygen saturation(%) during anesthesia induction


Secondary Outcome Measures :
  1. 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 ]
    The incidence of hypertension, hypotension, tachycardia and bradycardia from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery is recorded

  2. 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 ]
    The incidence of treatment-related adverse events as assessed by CTCAE v4.0



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Ⅲ-Ⅳ;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673723


Locations
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China, Anhui
Anqing Municipal Hospital
Anqing, Anhui, China, 231402
Chaohu Affiliated Hospital of Anhui Medical University
Chaohu, Anhui, China, 238000
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
The second People's Hospital of Wuhu
Wuhu, Anhui, China, 241000
Sponsors and Collaborators
The First Affiliated Hospital of Anhui Medical University
Investigators
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Principal Investigator: Wei Er Gu, PhD,MD First affiliated Hospital of Anhui Medical University Locations: China,
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Responsible Party: Xinqi Cheng, Clinical Professor of Anesthesia Department, The First Affiliated Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT02673723    
Other Study ID Numbers: FirstHAnhuiMU
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xinqi Cheng, The First Affiliated Hospital of Anhui Medical University:
docozine