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Comparison between remifentanyl and dexmedetomidine in patients undergoing modified radical mastoidectomy under conscious sedation

Comparison of remifentanyl vs dexmedetomidine in patients undergoing Modified Radical Mastoidectomy under Conscious sedation - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088091
Enrollment
45
Registered
2025-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: H60-H95- Diseases of the ear and mastoid process

Interventions

Intervention1: Monitored Anesthesia care for Modified Radical Mastoidectomy with Dexmedetomidine: The intervention group receives Dexmedetomidine. An initial intravenous bolus dose of zero point four

Sponsors

Institute of Medical Sciences, Banaras Hindu University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The inclusion criteria for the study are as follows. Patients should be between the age group of eighteen to sixty years. Only those posted for Modified Radical Mastoidectomy with Tympanoplasty under local anaesthesia with conscious sedation are eligible. Additionally, participants must belong to the American Society of Anaesthesiologists physical status classification one or two.

Exclusion criteria

Exclusion criteria: The exclusion criteria for the study include patients who refuse to participate and those who are either above sixty years of age or below eighteen years. Patients with obesity, defined as a body mass index greater than thirty four kilograms per metre square, are excluded. Also excluded are individuals with preoperative hypertension, coronary artery disease, cardiac conduction block, recent myocardial infarction within the past six weeks, or a forced expiratory volume in one second less than zero point eight. Furthermore, patients with severe renal, hepatic, or respiratory diseases, those with heart failure classified as New York Heart Association class greater than three, pregnant women, individuals dependent on oxygen therapy, and those with allergies to any of the study drugs will not be included. Patients classified under American Society of Anaesthesiologists class three or higher are also excluded from the study.

Design outcomes

Primary

MeasureTime frame
Satisfaction score of patient and surgeon using Likert scale Timepoint: At the time of incision, thirty minutes post operatively, one hour postoperatively

Secondary

MeasureTime frame
Postoperative pain score using VAS Anxiety score before and after procedure Sedation score using Ramsay sedation score Haemodynamic variability comparison Requirement of adjuvant drugs Timepoint: At one hour after surgery Preoperative and one hour postoperative Thirty minutes to one hour after administration Intraoperative period During the procedure

Countries

India

Contacts

Public ContactDr AK Paswan

Institute of Medical Sciences, Banaras Hindu University

dranil1973@gmail.com9794855871

Outcome results

None listed

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