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NCT Number: NCT02673723

The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation

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.

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Key information

Conditions

Awake Tracheal Intubation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anqing Municipal Hospital, Anqing, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent；
  • Selective surgery and general anesthesia patients；
  • Age 18-65 yrs；
  • Anesthesia Society of American (ASA) Scale I~II；

Exclusion criteria

  • Mallampatis Ⅲ-Ⅳ；
  • Heat rate < 50 beats/minutes；
  • II-III Atrioventricular block；
  • Use of alpha agonist or antagonist within two weeks；
  • Use of opioid within 24 hours；
  • Serious heart, liver, kidney disease and cerebrovascular disease；
  • Allergic to the trial drug and other anesthesia drug contraindication；
  • Factors existed that affect language communication；
  • Any respiratory disease；
  • Unsuccessful intubation for 3 times or drop out during intubation.

Treatment and study plan

Docozine

Drug

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

Saline

Drug

The same amount of saline is given for 10 seconds after surface anesthesia

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Official study title

The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation-a Multiple Center, Randomized, Controlled，Double Blinded Clinical Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 4, 2016
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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