The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation

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

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.

Study Overview

• Status: Completed
• Conditions: Awake Tracheal Intubation
• Intervention / Treatment: Drug: Docozine; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Anqing, Anhui, China, 231402
      • Anqing Municipal Hospital
    • Chaohu, Anhui, China, 238000
      • Chaohu Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China, 230601
      • Second Affiliated hospital of Anhui Medical University
    • Wuhu, Anhui, China, 241000
      • The Second People's Hospital of WuHu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of cardiovascular events	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	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	The incidence of treatment-related adverse events as assessed by CTCAE v4.0	from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Anhui Medical University
• Investigators: Principal Investigator: Wei Er Gu, PhD,MD, First affiliated Hospital of Anhui Medical University Locations: China,

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: January 23, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: docozine
• Other Study ID Numbers: FirstHAnhuiMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED