Application of Low-dose Muscle Relaxants in Bronchoscopic Interventional Procedures

NCT07035301 | Completed

• 1 other identifier: ChiCTR2500098978
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Disease of Respiratory System

Keywords

Interventional bronchoscopy; Airway control; Remimazolam; Remifentanil; Rocuronium

Outcome Measures

Primary Outcomes (1)

• The incidence rate of laryngeal spasm

  Observe the degree of glottic opening (grade I: glottis opens well; grade II: glottis opens \>⅔, mild laryngospasm; grade III: glottis opens ⅓-⅔, moderate laryngospasm; grade IV: glottis opens ≤⅓ or is completely closed, severe laryngospasm).Grades III and IV were defined as laryngospasm.

  At the beginning of the operation

Secondary Outcomes (39)

• The severity of postoperative sore throat

  When the patient regained consciousness (assessed up to 30 minutes after surgery)

• Dysphagia

  When the patient regained consciousness (assessed up to 30 minutes after surgery)

• The incidence of oxygen desaturation (SpO₂ < 92%) during mask ventilation

  during anesthesia induction

• Grading of body movement during bronchoscope insertion

  At the beginning of the operation

• Grading of chest wall rigidity

  During the process of anesthesia induction

Study Arms (2)

normal saline

PLACEBO COMPARATOR

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

Drug: Normal Saline (Placebo); Drug: Lidocaine Intravenous Infusion; Drug: Remimazolam Tosilate; Drug: Remifentanil

rocuronium bromide

EXPERIMENTAL

Using rocuronium for anesthesia during the induction phase of anesthesia.

Drug: Lidocaine Intravenous Infusion; Drug: Remimazolam Tosilate; Drug: Remifentanil; Drug: Rocuronium (0.15mg/kg/body mass)

Interventions

Normal Saline (Placebo) DRUG

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

normal saline

Lidocaine Intravenous Infusion DRUG

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

normal saline; rocuronium bromide

Remimazolam Tosilate DRUG

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

normal saline; rocuronium bromide

Remifentanil DRUG

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

normal saline; rocuronium bromide

Rocuronium (0.15mg/kg/body mass) DRUG

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

rocuronium bromide

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Harbin Medical University: lead
• First Affiliated Hospital of Harbin Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

MeSH Terms

Interventions

Saline Solution; Remifentanil; Rocuronium

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• SHI Jinghui SHI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate student

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 25, 2025
• Study Start: March 17, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)