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Comparing two medicines for putting a tube in the windpipe for breathing in patients whose mouth does not open fully

Comparison of propofol and dexmedetomidine sedation for awake C Mac D Blade videolaryngoscopic intubation in difficult airway cases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023678
Enrollment
60
Registered
2020-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: C04- Malignant neoplasm of floor of mouth

Interventions

Intervention1: Propofol: Administered once by an intravenous route of administration (infusion(50-100 mcg/kg/min) plus additional boluses(20 mg) if required,over 10 min to attain a BIS of 65-70 just b

Sponsors

Rajiv Gandhi Cancer Institute and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I- III Having anticipated difficult airway (EL GANZOURI SCORE 4-10) Mouth opening/ interincissor gap > 1.5cm/1 finger Requiring naso-trachial intubation for head and neck surgery.

Exclusion criteria

Exclusion criteria: Mouth opening/ interincissor gap ASA IV-V Alcoholic, Liver cirrhosis Severe bradycardia AV block on ECG Heart failure Thrombocytopenia/ coagulopathy contraindicating naso-tracheal intubation. Consent not given by patient. El ganzouri index >=10

Design outcomes

Primary

MeasureTime frame
Recording the incidence of coughing, vocal cord movement and patient reaction to ETT placement and comparison of propofol & dexmedetomidine for intubating conditions as determined by the intubation score. Timepoint: Once;at the time of intubatuion

Secondary

MeasureTime frame
Intubation time (Laryngoscopy to intubation) Timepoint: Once;at the time of intubatuion;No. of intubation attempts Timepoint: Once;at the time of intubatuion;Incidence of failed intubation Timepoint: Once;at the time of intubatuion;Rating the glottic view (POGO score) Timepoint: Once;at the time of intubatuion;Complications Timepoint: Once;at the time of intubatuion;Heart rate Timepoint: Baseline At the time of laryngoscopy At the time of intubatuion 1 min post-intubation 3 min post-intubation 5 min post-intubation ;Amount of study drug (propofol/dexmedetomidine) used Timepoint: Once 3 min after intubatuion;Mean arterial pressureTimepoint: Baseline At the time of laryngoscopy At the time of intubatuion 1 min post-intubation 3 min post-intubation 5 min post-intubation ;Oxygen saturation(SPO2)Timepoint: Baseline At the time of laryngoscopy At the time of intubatuion 1 min post-intubation 3 min post-intubation 5 min post-intubation ;Bi-spectral indexTimepoint: Baseline At the time of laryngoscopy At the time of intubatuion 1 min post-intubation 3 min post-intubation 5 min post-intubation

Countries

India

Contacts

Public ContactDr Gunjan Vishnoi

Rajiv Gandhi Cancer Institute and Research Centre

shah.shagun@rgcirc.org09891769779

Outcome results

None listed

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