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A Prospective Randomized comparative study of Inj Dexmedetomidine and Inj Fentanyl for conscious sedation in Middle Ear Surgery under Monitored Anesthesia Care.

A COMPARATIVE STUDY OF IV DEXMEDETOMIDINE INFUSION VERSUS IV FENTANYL INFUSION FOR CONSIOUS SEDATION DURING MIDDLE EAR SURGERIES UNDER MONITORED ANAESTHESIA CARE-A RANDOMIZED CONTROLLED PILOT STUDY - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079667
Enrollment
40
Registered
2025-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: H721- Attic perforation of tympanic membrane

Interventions

Intervention1: Interevention 1:IV Dexmedetomidine infusion,loading dose of 1mcg/kg over 10 minutes followed by infusion at 0.5 mcg/kh/hr Purpose: Consious sedation during middle ear surgery Intervent

Sponsors

Armed Forces Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age: 18-60 years Patients of either sex ASA Grade: I and II Patients undergoing middle ear surgeries under local anesthesia with MAC Patients consenting to the procedure

Exclusion criteria

Exclusion criteria: Pregnancy and Lactating women Patients with Asthma Patients on Beta Blocker drugs MI in last 6 months, AF, Heart blocks Deranged renal profile Advanced liver disease (liver enzymes twice the normal range or higher) History of chronic use of sedatives, narcotics and alcohol Known sensitivity to Lignocaine or allergy to study drugs

Design outcomes

Primary

MeasureTime frame
comparision of intraoperative sedation using the Ramsay Sedation Score,hemodynamic stabilityTimepoint: Intraoperative sedation using the Ramsay Sedation Score at 5 minutes, 15 minutes, and 30 minutes after the initiation of infusion.—

Secondary

MeasureTime frame
To assess intraoperative and postoperative analgesia. To assess intraoperative hemodynamic stability. To assess the quality of the surgical field for the surgeon s satisfaction. To assess the need for rescue analgesia. To assess any side effects, if present. Timepoint: 5 minutes, 15 minutes, and 30 minutes after the initiation of infusion.—

Countries

India

Contacts

Public ContactAjit Bhardwaj

Armed Forces Medical college,Pune

rainaajit@gmail.com8171505533

Outcome results

None listed

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