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A Study to Compare the Amount of Anesthesia Medicine (Propofol) Needed When Guided by Brain Monitoring versus Patient?s Response to Voice?

Comparison Between Entropy-Guided and Loss of Response to Verbal Command-Guided Propofol Dose Requirement for Induction of General Anesthesia - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094329
Enrollment
112
Registered
2025-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention1: Nil: Nil Intervention2: Entropy guided propofol dose requirement: In this group, the dose of propofol for induction of general anesthesia will be titrated using entropy monitoring, wher

Sponsors

ABVIMS and Dr Ram Manohar Lohia Hospital New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective surgical procedures under general anaesthesia. Adults aged between 18 to 65 years. American Society of Anesthesiologists ASA physical status I or II patients

Exclusion criteria

Exclusion criteria: History of substance abuse,including alcohol or recreational drugs Inability to comprehend or communicate effectively body mass index more than 30 Known sensitivity to any study drug. Pregnant females Patients with neurological disease, hearing disability and on drugs such as antipsychotics, benzodiazepines and/or anti-seizure medication

Design outcomes

Primary

MeasureTime frame
Dose of propofol at SE less than 50 and RE-SE difference less than 10 or at loss of response to verbal command Timepoint: T2 ? After induction at the target endpoint. Group E: the moment SE less than 50 and RE?SE difference less than 10 are achieved. Group V: the moment there is no response to two loud verbal commands.—

Secondary

MeasureTime frame
Hemodynamic parameters HR,SBP,DBP,MAP at baseline before induction of anesthesia (T1),after induction of anesthesia (T2),during tracheal intubation (T3),and at 1 minute after intubation (T4) & 5 minutes after tracheal intubation (T5)Timepoint: T1: Baseline ? after monitors, before induction. T2: Post-induction ? at endpoint (Group E: SE less than 50 & RE?SE difference less than 10; Group V: no response to 2 verbal commands). T3: During intubation ? at laryngoscopy/tube placement. T4: 1 min after intubation. T5: 5 min after intubation (study endpoint).—

Countries

India

Contacts

Public ContactDr Nang Sujali Choupoo

ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi

sujalichoupoo@yahoo.com8587887234

Outcome results

None listed

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