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To compare the sedative effects of intravenous dexmedetomidine and nalbuphine with intravenous dexmedetomidine and fentanyl in middle ear surgeries

Intravenous sedation for middle ear surgery-Comparison of i.v.Dexmedetomidine+Nalbuphine with i.v.Dexmedetomidine+ Fentanyl

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028320
Enrollment
80
Registered
2020-10-09
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: H60-H95- Diseases of the ear and mastoid process

Interventions

Intervention1: Drug combination: Drug combination will be given to the patient through intravenous rout Intervention2: Sedation score comparison: Drug combination will be given to the patient through

Sponsors

Shree Krishna Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patient of ASA(American Society of Anaesthesiology)1-2 physical status 2)Undergoing middle ear surgery

Exclusion criteria

Exclusion criteria: 1)Hypertension 2)Hypersensitivity to local anaesthesia 3)Hypersensitivity to dexmedetomidine,nalbuphine,fentanyl 4)Renal impairment,advanced liver disease,history of alcohol or drug abuse

Design outcomes

Primary

MeasureTime frame
Ramsay Sedation ScoreTimepoint: intraoperatively at 2,4,6,8,10,30,60,90,120 min—

Secondary

MeasureTime frame
Heart Rate,Respiratory rate,blood pressure,spo2,likert scale,Timepoint: intraoperatively at 2,4,6,8,10,30,60,120 min—

Countries

India

Contacts

Public ContactDr Khushbu S Gadhiya

H M Patel Center for Medical Care and Education

Vaibhavih@charutarhealth.org09909977446

Outcome results

None listed

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