Dezoxide Suppresses Sufentanil-induced Cough

Low-dose Dezoxide Suppresses Sufentanil-induced Cough During Induction of General Anesthesia in Patients Undergoing Cardiac Surgery: a Prospective, Randomized, Controlled Trial

Dizocine (0.03 mg/kg) or saline followed by sufentanil 0.4ug/kg was administered, and induction was completed with 3 min of observation. Heart rate and mean arterial pressure (MAP) were recorded before induction of anesthesia, before and 1 min after intubation, and side effects during induction, such as vomiting, hypoxemia (SpO2 <90%), or other expected effects. The number of coughs was recorded in both groups, and the severity of cough was defined as follows: mild, 1-2 coughs; moderate, 3-4 coughs; severe, 5 or more coughs.

Study Overview

• Status: Not yet recruiting
• Conditions: Sufentanil-induced Cough
• Intervention / Treatment: Drug: Intravenous dizocine

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients admitted for elective valve surgery, artificial vessel replacement or coronary artery bypass graft surgery; Age 18~80 years old; Sex is not limited; ASA class II~III; NYHA Class II-III; Patients or their family members have signed the clinical trial informed consent form

Exclusion Criteria:

• Upper respiratory tract infection within the last two weeks; Long history of smoking; chronic obstructive pulmonary disease; Highly reactive airway diseases such as bronchitis and asthma; Presence of high cranial pressure, high eye pressure, pulmonary alveolus; Malignant tumor, hematological disease, severe liver and kidney dysfunction, recent serious infection, etc.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: Dezocine; intravenous dezocine (0.03mg/kg diluted to 5 ml)	Drug: Intravenous dizocine; Intravenous dizocine (0.03mg/kg diluted to 5 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sufentanil-induced cough	rate and severity of cough after sufentanil injection	2 minutes after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	heart rate during induction of general anesthesia	2 minutes after intubation
mean arterial pressure	mean arterial pressure during induction of general anesthesia	2 minutes after intubation
SpO2	SpO2 during induction of general anesthesia	2 minutes after intubation

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 12, 2022
• Primary Completion (Anticipated): September 12, 2022
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 4, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 2022 Dezocine

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No