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A randomized control trial comparing recovery profile of patients posted for tympanoplasty under total intravenous anaesthesia with qCON and BIS guided depth of anaesthesia monitoring systems

A randomized control trial comparing recovery profile of patients posted for tympanoplasty under total intravenous anaesthesia with qCON and BIS guided depth of anaesthesia monitoring systems - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087640
Enrollment
54
Registered
2025-05-26
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: H958- Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified

Interventions

Control Intervention1: BIS Monitor: Bispectral Index (BIS Index) and qCON are numerical processed, clinically confirmed EEG parameters obtained by combining several advanced technologies which are com

Sponsors

Bharati Hospital and Research Centre Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All elective tympanoplasty surgeries under Total Intravenous Anaesthesia lasting between 1.5 to 3 hours 2.Patient categorized under American Society of Anaethesiology Categories I, II and III.

Exclusion criteria

Exclusion criteria: 1. Patients categorized under American Society of Anaethesiology Categories IV and above. 2. Patients unwilling to sign the written consent. 3. Patients that require mechanical ventilation or do not have a patent airway.

Design outcomes

Primary

MeasureTime frame
To compare time for eye opening of patients posted for tympanoplasty under total intravenous anaesthesia with qCON and BIS guided depth of anaesthesia monitoring systems.Timepoint: After stopping of Infusions. Time at which primary outcome is achieved will be noted down

Secondary

MeasureTime frame
i. To compare the amount of Propofol required per hour between qCON & BIS guided depth of anaesthesia monitoring systems.Timepoint: After the stopping of infusions. Immediately after the surgery gets over;ii. To evaluate the Ramsay Sedation Score- 0, 15 & 30 mins after the end of infusion & compare them for qCON & BIS guided depth of anaesthesia monitoring systemsTimepoint: 0, 15 & 30 mins after the end of infusion

Countries

India

Contacts

Public ContactSiddhant Sugandhi

Bharati Hospital and Research Centre

drabhaysancheti19@gmail.com9371107686

Outcome results

None listed

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