Application of Low-dose Muscle Relaxants in Bronchoscopic Interventional Procedures

Harbin Medical University

Status: Enrolling

Conditions: Disease of Respiratory System

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07035301

ChiCTR2500098978

Details and patient eligibility

About

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.

Full description

Patients scheduled for elective bronchoscopy were randomly allocated to two groups: the muscle relaxant group and the non-muscle relaxant group.

Anesthesia Induction:

Muscle Relaxant Group: Intravenous injection of lidocaine (0.5 mg/kg), remimazolam (0.2 mg/kg), remifentanil (3 µg/kg), and rocuronium bromide (0.15 mg/kg).

Non-muscle Relaxant Group: Identical to the muscle relaxant group, except rocuronium bromide was replaced with an equivalent volume of normal saline.

In both groups, an appropriately sized laryngeal mask airway (LMA) was inserted using a standard technique.

Anesthesia Maintenance:

A continuous intravenous infusion of remimazolam was administered at a rate of 1 mg/kg/h, and remifentanil was infused at a rate of 0.25-0.5 µg/kg/min.

Primary Outcomes:The grading of chest wall rigidity, the incidence of difficult facemask ventilation, the incidence of SpO₂ < 92% during facemask ventilation, the incidence of laryngospasm, and the grading of cough and/or body movement during bronchoscope insertion.

Secondary Outcomes:Perioperative changes in blood pressure, heart rate, oxygen saturation, Bispectral Index (BIS), airway pressure, and end-tidal carbon dioxide (PETCO₂); LMA insertion conditions (time, number of attempts, and ease of insertion); dosage of anesthetic drugs used during the procedure; the incidence of intraoperative and postoperative adverse events; and the quality of postoperative recovery.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups, including a placebo group

normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Remifentanil

Drug: Normal Saline (Placebo)

Drug: Remimazolam Tosilate

Drug: Lidocaine Intravenous Infusion

rocuronium bromide

Experimental group

Description:

Using rocuronium for anesthesia during the induction phase of anesthesia.

Treatment:

Drug: Remifentanil

Drug: Remimazolam Tosilate

Drug: Lidocaine Intravenous Infusion

Drug: Rocuronium (0.15mg/kg/body mass)