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Comparison of sedation between two group of anaesthestic drugs namely dexmedetomidine with a combination of ketamine and midazolam for awake endotracheal tube introduction by using fibre optic bronchoscopy.

Comparison of dexmedetomidine with a combination of ketamine and midazolam for sedation during awake fibre optic nasal intubation , a randomized double blind comparative trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011141
Enrollment
60
Registered
2018-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: null- - Age 18-65yrs - ASA I-III - Posted for surgery under general anesthesia. - Requiring nasotracheal intubation Health Condition 2: C01- Malignant neoplasm of base of tongue

Interventions

Intervention1: nil: nil Control Intervention1: dexmedetomidine: Study groups: Group Dââ?¬â?? 1mcg/kg of dexmedetomidine,Group KMââ?¬â?? 0.5mg /kg ketamine and 0.02mg/kg midazolam Blinding: Patient a

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA I-III 2.Posted for surgery under general anesthesia. 3.Requiring nasotracheal intubation with any of the following i) Anticipated difficult airway based on physical examination ii) Anticipated difficult mask ventilation iii) Previous history of difficult intubation

Exclusion criteria

Exclusion criteria: 1.Patientââ?¬•s refusal 2.BMI > 35 3.Allergy to study medication 4.History suggestive of gastro-oesophageal reflex 5.Pregnancy 6.hepatic or renal disorders 7.history of psychotropic drug intake or drug abuse 8.long term use of benzodiazepines or tricyclic antidepressants.

Design outcomes

Primary

MeasureTime frame
Difference in the cough score at the time of introduction of endotracheal tube through glottis.Timepoint: After introduction of fibre optic endoscopy into larynx ,then the endotracheal tube is inserted till the Etco2 detected in monitor .

Secondary

MeasureTime frame
Overall intubation scores . Post intubation score. Patient satisfaction score in postoperative period. Hemodynamic parameters in both group.Timepoint: Before introduction of fibre optic endoscopy till the Induction agent is given for general anaesthesia

Countries

India

Contacts

Public ContactSivakumar

AIIMS

rashmiramachandran1@gmail.com9489585737

Outcome results

None listed

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