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Comparative study between general anaesthesia without using drugs which reduces pain and plain general anaesthesia for stabilizing vitals in ear surgery:a prospective randomized clinical study

Comparision of opioid free general anaesthesia to conventinal general anaesthesia for hemodynamic stability in mastoid surgery A prospective randomized clinical study - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057341
Enrollment
80
Registered
2023-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: H673- Otitis media in diseases classified elsewhere, bilateral

Interventions

Intervention1: Opioid free general anaesthesia: We give magnesium sulfate as a dose of 40 mg/kg in 100 ml normal saline before 15 minutes of induction followed by dexmedetomidine as a dose of 0.5 mg/k

Sponsors

Baroda medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade 1 and 2 malampatti grade 1 and 2 patient diagnose with acute and chronic suppurative otitis media scheduled for mastoid surgery patient able to give written and informed consent patient able to understand Visual analogue scale regarding assessment of pain

Exclusion criteria

Exclusion criteria: Patient not willing for procedure patient having uncontrolled diabetes,hypertention,liver and kidney disorder pregnant patients hypersensitivity to any local anaesthetic drug or drug used in this study patient with significant history of drug or alcohol abuse,psychiatric illness patient on beta blocker and calcium channel blockers

Design outcomes

Primary

MeasureTime frame
The primary objective is to monitor hemodynamic stability intraoperativelyTimepoint: Baseline Before intubation During intubation After intubation Maintainance anaesthesia 2 min 5 min 10 min 20 min 30 min 60 min 90 min 120 min 150 min 180 min

Secondary

MeasureTime frame
To observe post operative pain relief( first rescue analgesia) post operative any complication like nausea & vomitingTimepoint: Immediately post operative,30 min,1 hr,2 hr,4 hr,6 hr,8 hr,12 hr,16 hr,20 hr

Countries

India

Contacts

Public ContactKumud ganvit

Baroda medical college, vadodara

drkumudsganvit@gmail.com9825607625

Outcome results

None listed

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