Clinical trial NCT02673723: The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation
Official title: The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation-a Multiple Center, Randomized, Controlled，Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Awake Tracheal Intubation
Keywords: docozine
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Sedation assessment
timeFrame: anesthesia induction
measure: The occurrence of cough response
timeFrame: anesthesia induction
measure: The variation of blood pressure
timeFrame: anesthesia induction
measure: The variation of heart rate
timeFrame: anesthesia induction
measure: The variation of pulse oxygen saturation
timeFrame: anesthesia induction
Secondary outcomes:
measure: The occurrence of cardiovascular events
timeFrame: from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery
measure: The occurrence of treatment-related adverse events
timeFrame: from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery
Other outcomes:
Locations:
city: Anqing
country: China
facility: Anqing Municipal Hospital
state: Anhui
city: Chaohu
country: China
facility: Chaohu Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Wuhu
country: China
facility: The second People's Hospital of Wuhu
state: Anhui
Study officials:
affiliation: First affiliated Hospital of Anhui Medical University Locations: China,
name: Wei Er Gu, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: