Dezoxide Suppresses Sufentanil-induced Cough

NCT ID: NCT05532449

Last Updated: 2022-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sufentanil-induced Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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control

Group Type NO_INTERVENTION

No interventions assigned to this group

Dezocine

intravenous dezocine (0.03mg/kg diluted to 5 ml)

Group Type EXPERIMENTAL

Intravenous dizocine

Intervention Type DRUG

Intravenous dizocine (0.03mg/kg diluted to 5 ml)

Interventions

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Intravenous dizocine

Intravenous dizocine (0.03mg/kg diluted to 5 ml)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2022 Dezocine

Identifier Type: -

Identifier Source: org_study_id

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