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A Study to assess role of Nitrous Oxide Anaesthesia on graft uptake in Tympanoplasty surgery in children.

The effect of Nitrous Oxide Anaesthesia on the outcomes of Underlay Tympanoplasty Type 1 in Children : A Randomised Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025003
Enrollment
60
Registered
2020-05-04
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: H720- Central perforation of tympanic membrane Health Condition 2: H661- Chronic tubotympanic suppurative otitis media

Interventions

Intervention1: Continuous Nitrous Oxide Anaesthesia: All the cases will undergo Tympanoplasty Type 1 by using post auricular inlay technique with temporalis fascia graft, under general anaesthesia.. N

Sponsors

Lady Hardinge Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients having Chronic Suppurative Otitis Media mucosal disease both unilateral and bilateral will be included. 2. Patients having perforation in pars tensa for a minimum period of three months. 3.Patients having a dry ear period of four weeks.

Exclusion criteria

Exclusion criteria: 1.Patients with Cholesteatoma in the ear. 2.Patients with granulation tissue in the ear 3.Patients with previously operated ear. 4.Patients with only one hearing ear. 5.Patients with hearing loss out of proportion to the size of perforation. 6.Patients with any congenital anomalies like cleft lip, cleft palate and syndromal diagnosis.

Design outcomes

Primary

MeasureTime frame
Graft uptake success rate in paediatric tympanoplasty with and without N2O anaesthesiaTimepoint: 3 months postoperatively

Secondary

MeasureTime frame
Audiological Success rate in Paediatric Tympanoplasty with and without N2O anaesthesia Timepoint: 3 months postoperatively;Correlation of graft uptake with Eustachian Tube functionTimepoint: 3 months postoperatively

Countries

India

Contacts

Public ContactDr Gautam Bir Singh

Lady Hardinge Medical College

gbsnit@yahoo.co.in9818836242

Outcome results

None listed

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