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To study the efficacy of dexmedetomidine versus fentanyl for Proseal Laryngeal Mask Airway insertion

A prospective, randomised, double blind Entropyâ?¢ guided approach to evaluate the efficacy of different doses of dexmedetomidine with propofol versus fentanyl with propofol for ProSeal Laryngeal Mask Airway insertion.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013407
Enrollment
120
Registered
2018-04-23
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: null- ASA I,II,III

Interventions

Intervention1: FENTANYL AND DEXMEDETOMIDINE: DIFFERENT DOSES OF DEXMEDETOMIDINE AND FENTANYL

Sponsors

SDM Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA physical status I, II, III

Exclusion criteria

Exclusion criteria: 1.Anticipated difficult airway 2.BMI Ë?30 kg/m2 3.Smoker 4.Patient with risk of aspiration, Gastro-oesophageal reflux 5.Undergoing head and neck surgery 6.Patients with heart rate less than 60 b/min 7.Patients on sedatives 8.Patients not consenting for the study.

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of 3 different doses of dexmedetomidine with propofol in providing optimal conditions for insertion of PLMA and compare with that of fentanyl with propofol using scoring system modified by Muzi and colleaguesTimepoint: 5 minutes after PLMA insertion—

Secondary

MeasureTime frame
1.Haemodynamic changes during PLMA insertion 2.Entropy (SE and RE) changes during PLMA insertion 3.Dose of propofol for PLMA insertion 4.Motor response to Jaw thrust 5.Number of attempts at PLMA insertion 6.Time taken for insertion 7.Incidence of hypotension and/or bradycardia 8.Incidence of desaturation (SpO2 94%) 9.Incidence and duration of apnoea 10.Coughing, gagging, bronchospasm or laryngospasmTimepoint: 5 minutes after PLMA insertion—

Countries

India

Contacts

Public ContactDR BITSON PAZHOOR THOMAS

M.B.B.S M.D, (Anesthesia)

drmontygoudar@yahoo.co.in7829164500

Outcome results

None listed

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