Awake fiberoptic intubation: patient comfort, intubating conditions and hemodynamic stability during conscious sedation with different doses of remimazolam

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075614

Enrollment

Unknown

Registered

2023-09-11

Start date

2023-09-11

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult airway

Interventions

remimazolam 1 group :2.0mg/Kg·h remimazolam for sedation(1 minute)

remimazolam 2 group:3.0mg/Kg·h remimazolam for sedation(1 minute)

remimazolam 3 group:4.0mg/Kg·h remimazolam for sedation(1 minute)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients of either sex between 18-65 years of age, belonging to the American Society of Anesthesiologists (ASA) physical status I-II with an anticipated diffificult airway (limited mouth opening < two fingers or mouth opening less than 3 cm, restriction of neck mobility, or lack of space for laryngoscopy) planned for elective surgery enrolled for the study.

Exclusion criteria

Exclusion criteria: lack of cooperation or effective communication, patient’s refusal for consent, Pregnant or lactating women, history of drug or alcohol abuse, and patients on longterm opioids or sedative medication or tricyclic antidepressants, known allergy to one of the study medications, cardiovascular abnormalities(any type of AV block demonstrated in electrocardiogram),Patients requiring emergency surgery, bradycardia (heart rate [HR] <50 beats/minute),systolic blood pressure(SBP)<90mmHg, severe neurological, psychiatric , hepatic, renal, or pulmonary diseases, and bleeding disorders, a nasal mass, a history of nasopharyngeal surgery, history of acute unstable angina, uncontrolled seizure disorder, presence of increased intracranial pressure or cerebrospinal fluid leak, patients with gastro-esophageal reflux.

Design outcomes

Primary

Measure	Time frame
the times taken to achieve sedation (RSS=2);Airway obstruction score was also assessed (1 = patient airway, 2 = airway obstruction relieved by neck extension, 3 = airway obstruction requiring jaw retraction). ;the level of patient sedation was assessed using the Ramsay Sedation Scale ,systolic blood pressure (SBP), diastolic blood pressure(DBP), mean arterial pressure(MAP),heart rate (HR), and peripheral oxygen saturation(SpO2) ,end-tidal carbon dioxide (PetCO2),respiratory frequency ,the value of bispectral index (BIS) were recorded one minute before starting drug infusion and every minute until tracheal intubation;any episode of adverse events and therapeutic measures;a post-operative visit was undertaken the day after operation during which the level of recall and satisfaction scores;	—

Measure

Time frame

the times taken to achieve sedation (RSS=2);Airway obstruction score was also assessed (1 = patient airway, 2 = airway obstruction relieved by neck extension, 3 = airway obstruction requiring jaw retraction). ;the level of patient sedation was assessed using the Ramsay Sedation Scale ,systolic blood pressure (SBP), diastolic blood pressure(DBP), mean arterial pressure(MAP),heart rate (HR), and peripheral oxygen saturation(SpO2) ,end-tidal carbon dioxide (PetCO2),respiratory frequency ,the value of bispectral index (BIS) were recorded one minute before starting drug infusion and every minute until tracheal intubation;any episode of adverse events and therapeutic measures;a post-operative visit was undertaken the day after operation during which the level of recall and satisfaction scores;

—

Secondary

Measure	Time frame
total dose of remimazolam required;	—

Countries

China

Contacts

Public ContactWen Wen

Affiliated Hospital of North Sichuan Medical College

252973992@qq.com+86 182 8119 7216

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026