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Evaluation of Effectiveness of Remimazolam on Sedation and Safety during Awake Fiberoptic Intubation

Evaluation of Effectiveness of Remimazolam on Sedation and Safety during Awake Fiberoptic Intubation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075948
Enrollment
Unknown
Registered
2023-09-20
Start date
2023-09-21
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Difficult airway

Interventions

the group of Remimazolam(group R) :remimazolam for sedation
the group of Dexmedetomidine(group D):dexmedetomidine for sedation

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ASA I-II grade patients aged 18-65 who have anticipated difficult airways and a BMI of 35 = 45Kg/m2 (mouth opening less than 2 fingers or less than 3cm, limited neck mobility, and no space for laryngoscopy).

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

MeasureTime frame
Airway obstruction score was also assessed (1 = patient airway, 2 = airway obstruction relieved by neck extension, 3 = airway obstruction requiring jaw retraction). ;

Secondary

MeasureTime frame
the times taken to achieve sedation (RSS= 2);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;episode of adverse events and therapeutic measures ;a post-operative visit was undertaken the day after operation during which the level of recall (memory of pre-anaesthetic preparations, topical anaesthesia, endoscopy and intubation), and satisfaction scores(1 = excellent, 2 = good, 3 = fair, 4 = poor).;

Countries

China

Contacts

Public ContactWen Wen

Affiliated Hospital of North Sichuan Medical College

18281197216@163.com+86 182 8119 7216

Outcome results

None listed

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