A clinical trial to study the effect of two drugs, Dexmedetomidine and Fentanyl in patients requiring ear surgery

Comparison of Dexmedetomidine and Fentanyl for tympanoplaty surgery under Monitored Anaesthesia Care

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011126

Enrollment

Registered

2018-01-04

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- Patients undergoing tympanoplasty surgery

Interventions

Intervention1: Injection Dexmedetomidine: Injection dexmedetomidine 1 microgram/kg over 10 minutes i.v infusion as loading dose and maintenance dose as 0.5 microgram/kg/hour i.v Control Intervention1

Eligibility

Inclusion criteria

Inclusion criteria: Patients willing to give informed and written consent Patients belonging to ASAphysical status I and II Patients posted for planned surgery

Exclusion criteria

Exclusion criteria: Patients with severely compromising respiratory/cardiac/renal and hepatic dysfunction Morbidly Obese patients Pregnant and lactating women Patient with anticipated difficult airway

Design outcomes

Primary

Measure	Time frame
Ramsay sedation score Boezaart scale Hemodynamic parametersTimepoint: every half an hourly intraoperatively Boezaart scale-throughout surgery Hemodynamic parameters-throughout surgery	—

Secondary

Measure	Time frame
VAS ScoreTimepoint: every half an hourly postoperatively till VAS score is more than 4	—

Countries

India

Contacts

Public ContactDr Suman Shekhar Tiwari

Dhiraj general hospital

rinkushekhar@gmail.com919978621648

Outcome results

None listed

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