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Comparison of two drugs,dexmedetomidine and midazolam for sedation during awake fiberoptic intubation

Comparison of Dexmedetomidine vs Midazolam for sedation during awake fiberoptic intubation-A randomized interventional study in oral cancer surgeries at SMS medical college Jaipur during 2018-2019

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020698
Enrollment
60
Registered
2019-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: IV Inj Midazolam : GROUP 1(MDZ) - Subjects will receive Intravenous Midazolam 0.05mg/kg bolus in 10 ml normal saline over 10 minutes followed by infusion at the rate of 0.1 mg/kg/hr whi

Sponsors

Department of AnaesthesiologySMS Medical collegeJaipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing oral cancer surgeries requiring nasal intubation. Patients willing to give written informed consent. Patients of either sex ASA Grade II & III Age Groups-18-60 years Weighing 40 to 70 kg â?? BMI

Exclusion criteria

Exclusion criteria: Patient refusal. Known or admitted alcohol or drug abusers. Allergic to the drugs involved in the study. Bleeding disorders. Existing cardiovascular diseases.

Design outcomes

Primary

MeasureTime frame
To determine the difference in patient comfort score during intubation in both the groups.Timepoint: Comfort Scale values will be recorded during preoxygenation (Pre-Ox), at introduction of fiberoptic scope (time point designated as FOS), and at introduction of the endotracheal tube (time point designated as ET).—

Secondary

MeasureTime frame
1.To determine the difference in hemodynamic variables(HR,SBP,DBP,SpO2) at different time intervals in both the groups. 2.To determine the difference in patients tolerance during intubation in both the groups. 3.To determine the difference in patient satisfaction in both the groups. 4.To find out adverse reactions to the drugs if any. Timepoint: Heart rate,systolicBP, and diastolicBP,SpO2 will be recorded at the end of loading dose of study drug and then at 1 minute intervals until the placement of endotracheal tube and 1 minute and 3 minute after intubation.One study blinded observer will assess patientâ??s reaction to placement of the fiberoptic scope and the endotracheal tube on a scale of 1 to 5.24 hours after the surgical procedure, each patient will be questioned to assess his/her experience with the AFOI.—

Countries

India

Contacts

Public ContactDR SHERBINA K M

Senior Professor,Anaesthesiology-SMS Medical college,Jaipur

reemadrrn@gmail.com9413237117

Outcome results

None listed

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