Application of Low-dose Muscle Relaxants in Bronchoscopic Interventional Procedures

NCT ID: NCT07035301

Last Updated: 2025-06-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this clinical trial is to observe the use of low-dose muscle relaxants in bronchoscopy intervention surgeries, compared with no muscle relaxants, in terms of the satisfaction of tracheal tube insertion after anesthesia induction, the incidence of laryngospasm, the grading of intraoperative cough and movement, and the recovery of patients after surgery. The main questions it aims to answer are:

* How safe and feasible is the use of low-dose muscle relaxants in bronchoscopy intervention surgeries?
* Is the muscle relaxant regimen better than the no-muscle-relaxant regimen?

Participants will:

* During anesthesia induction, the experimental group will use low-dose muscle relaxants for anesthesia, while the control group will not use muscle relaxants for anesthesia.
* Record the satisfaction of mask ventilation and the incidence of laryngospasm.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients scheduled for endoscopic interventional surgery were randomly divided into two groups: Group A (without muscle relaxation) and Group B (with muscle relaxation). Group A (intravenous administration of lidocaine 0.5mg/kg, remimazolam 0.2mg/kg, and remifentanil 3ug/kg); Group B (intravenous administration of lidocaine 0.5mg/kg, remimazolam 0.2mg/kg, remifentanil 3ug/kg, and rocuronium 0.15mg/kg). The total air flow rate was 6L/min, with oxygen-air ratio of 1:1. Both groups used standard techniques to insert the appropriate-sized laryngeal mask. The muscle rigidity grade after anesthesia induction, the satisfaction of laryngeal mask insertion, the incidence of laryngeal spasm, the grading of intraoperative cough, and the recovery of patients after surgery were recorded.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disease of Respiratory System

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

normal saline

During the induction of anesthesia, rocuronium is not used for anesthesia.

Group Type PLACEBO_COMPARATOR

Normal Saline (Placebo)

Intervention Type DRUG

During anesthesia induction, an equal volume of normal saline was used instead of rocuronium for anesthesia.

Lidocaine Intravenous Infusion

Intervention Type DRUG

Lidocaine was administered at a dose of 0.5mg/kg for the induction of anesthesia.

Remimazolam Tosilate

Intervention Type DRUG

Remimazolam was administered at a dose of 0.2 mg/kg for the induction of anesthesia.

Remifentanil

Intervention Type DRUG

Remifentanil was administered at a dose of 3 micrograms per kilogram for the induction of anesthesia.

rocuronium bromide

Using rocuronium for anesthesia during the induction phase of anesthesia.

Group Type EXPERIMENTAL

Lidocaine Intravenous Infusion

Intervention Type DRUG

Lidocaine was administered at a dose of 0.5mg/kg for the induction of anesthesia.

Remimazolam Tosilate

Intervention Type DRUG

Remimazolam was administered at a dose of 0.2 mg/kg for the induction of anesthesia.

Remifentanil

Intervention Type DRUG

Remifentanil was administered at a dose of 3 micrograms per kilogram for the induction of anesthesia.

Rocuronium (0.15mg/kg/body mass)

Intervention Type DRUG

Rocuronium was administered at a dose of 0.15mg/kg for the induction of anesthesia.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Normal Saline (Placebo)

During anesthesia induction, an equal volume of normal saline was used instead of rocuronium for anesthesia.

Intervention Type DRUG

Lidocaine Intravenous Infusion

Lidocaine was administered at a dose of 0.5mg/kg for the induction of anesthesia.

Intervention Type DRUG

Remimazolam Tosilate

Remimazolam was administered at a dose of 0.2 mg/kg for the induction of anesthesia.

Intervention Type DRUG

Remifentanil

Remifentanil was administered at a dose of 3 micrograms per kilogram for the induction of anesthesia.

Intervention Type DRUG

Rocuronium (0.15mg/kg/body mass)

Rocuronium was administered at a dose of 0.15mg/kg for the induction of anesthesia.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients undergoing elective electronic bronchoscopic interventional surgery;
2. Age 18 years or older;
3. American Society of Anesthesiologists (ASA) I-III;
4. The duration of bronchoscopic surgery \>=20min;
5. Through pre-anesthesia assessment, the patient/family member has informed consent and signed the consent form;
6. The general clinical information of the patient is complete.

Exclusion Criteria

1. Patients with predictable difficult airway;
2. Small mouth opening (\<2 transverse fingers);
3. Combined with severe cardiovascular disease, abnormal liver and kidney function;
4. Morbidly obese patients with body mass index (BMI) greater than 35kg/m\^2;
5. Has a history of gastroesophageal reflux disease.
6. High risk of reflux aspiration;
7. Those who have a history of abnormal surgical anesthesia recovery in the past;
8. Patients with mental illness and previous allergies to conventional anesthetic drugs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shi xiaoqian

Graduate student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

SHI Jinghui SHI

Role: STUDY_DIRECTOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

LIU Shujie LIU

Role: CONTACT

+86 138 4508 0390

SHI Xiaoqian SHI

Role: CONTACT

+86 188 3424 7923

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

LIU Shujie LIU

Role: primary

+86 138 4508 0390

SHI Xiaoqian SHI

Role: backup

+86 188 3424 7923

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ChiCTR2500098978

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Automated Anesthesia During Bronchoscopy
NCT00571181 COMPLETED PHASE4