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A Study to compare how patients come out of anesthesia after surgery and disability of thinking after coming out of anesthesia after mastoidectomy surgery between opioid and opioid free groups

A comparitive study of opioid free anesthesia with opioid base anesthesia for recovery characteristics and postoperative cognitive dysfunction after mastoidectomy surgeries - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067800
Enrollment
40
Registered
2024-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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: DEXMEDETOMIDINE infusion: DEXMEDETOMIDINE infusion 1mcgs/kg over 10mins before induction followed by DEXMEDETOMIDINE infusion 0.5mcgs/kg/hr post intubation and continued until before ex

Sponsors

Preethi S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age between 18 to 65 years ASA physical status 1 and 2

Exclusion criteria

Exclusion criteria: Taking opioid for chronic pain Pregnant and nursing women GCS less than 15 and heart rate less than 50 per min Allergic to study medications Psychiatric disorder and electrolyte imbalance Hepatic and renal insufficiency Unstable cardiorespiratory disorder

Design outcomes

Primary

MeasureTime frame
1)Emergence time 2)Extubation time 3)recovery of cognitive functionsTimepoint: 1)Emergence time from administration of reversal agent to eye opening 2)Extubation time from adminstration of reversal agent to tracheal extubation 3)recovery of cognitive functions assessed using Short Orientation Memory Concentration test ater extubation at 5, 10 and 15mins

Secondary

MeasureTime frame
1) Intraoperative hemodynamic stability 2)Postoperative pain assessmentTimepoint: 1)Intraoperatively patient monitored for hemodynamic stability by monitoring heart rate and blood pressure 2)Postoperatively pain was assessed at 2, 6, 12 and 24hours using Numeric rating scale

Countries

India

Contacts

Public ContactThamarai Selvi

Sri Ramachandra Institute Of Higher Education And Research

thamarai@sriramachandra.edu.in9841552333

Outcome results

None listed

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