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Comparison of drugs Dexmedetomidine and Pentazocine-promethazine in patients undergoing tympanoplasty under sedation

Comparison of Dexmedetomidine versus Pentazocine-Promethazine for Tympanoplasty under Monitored Anesthesia Care: Randomized Double Blind study - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063761
Enrollment
146
Registered
2024-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine In tympanoplasty under Monitored anaesthesia care: One group will receive inj. Dexmedetomidine 1mcg/kg in 10ml NS (normal saline ) over 10 minutes IV followed by it’s i

Sponsors

All India Institute of Medical Sciences, Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with chronic otitis media mucosal type posted for tympanoplasty. 2.Patients who have given consent for study. 3.Patients of ASA-PS I- II 4.Patients in the age group of 18-65 years of either sex.

Exclusion criteria

Exclusion criteria: 1.Patients undergoing mastiodectomy 2.Patients who are not willing for consent. 3.Patients of ASA-PS III, IV 4.Patients with known allergic history to local anaesthetics, dexmedetomidine, pentazocine and promethazine. 5.Patients with uncontrolled psychiatric illness. Pregnancy. 6.Patients with history of seizure disorder,neuroleptic malignant syndrome, heart failure,renal or liver failure. 7.Special group of population protected by the law and requires additional permission beyond the participant’s consent.

Design outcomes

Primary

MeasureTime frame
Primary : To compare the pain and sedation among the groups. Timepoint: Upto 4 hours post operatively

Secondary

MeasureTime frame
1.To compare recovery and immediate post operative outcome among the groups. 2.To compare patient’s comfort and surgeon’s satisfaction during surgery among the groups. 3. To compare side effects and hemodynamic variations from baseline among both the drugs. Timepoint: Upto 4 hours postoperatively

Countries

India

Contacts

Public ContactSwetha Yadavalli

All India Institute of Medical Sciences, Raipur

nkagarwal1963@gmail.com9373103294

Outcome results

None listed

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