The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation

NCT02673723 | Completed Phase 4 DMC

• 1 other identifier: FirstHAnhuiMU
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 4

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.

Conditions

Awake Tracheal Intubation

Keywords

docozine

Outcome Measures

Primary Outcomes (5)

• Sedation assessment

  Observer's assessment of alertness/sedation(OAA/S) scale is used to assess the depth of sedation during anesthesia induction

  anesthesia induction

• The occurrence of cough response

  The cough scale is used to assess cough response the during anesthesia induction

  anesthesia induction

• The variation of blood pressure

  The variation of blood pressure（mmHg) during anesthesia induction

  anesthesia induction

• The variation of heart rate

  The variation of heart rate(bpm）during anesthesia induction

  anesthesia induction

• The variation of pulse oxygen saturation

  The variation of pulse oxygen saturation(%) during anesthesia induction

  anesthesia induction

Secondary Outcomes (2)

• The occurrence of cardiovascular events

  from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery

• The occurrence of treatment-related adverse events

  from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery

Study Arms (2)

Dezocine

EXPERIMENTAL

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

Controlled

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

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

Dezocine

Saline DRUG

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

Controlled

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (4)

Anqing Municipal Hospital

Anqing, Anhui, 231402, China

Location

Chaohu Affiliated Hospital of Anhui Medical University

Chaohu, Anhui, 238000, China

Location

Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

The second People's Hospital of Wuhu

Wuhu, Anhui, 241000, China

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Wei Er Gu, PhD,MD

  First affiliated Hospital of Anhui Medical University Locations: China,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesia Department

Study Record Dates

• First Submitted: January 23, 2016
• First Posted: February 4, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CN (4)