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Comparing effectiveness of intraveinous Dexmedetomidine Mixture of ketamine and propofol (ketofol) and local infiltration of ropivacaine and determine that which drug causes significant decrease in rise in Blood pressure due to painful stress response of skull pins fixation in craniotomies

Comparative evaluation of intravenous Dexmedetomidine Mixture of Ketamine and Propofol (Ketofol) and Local Administration of Ropivacaine for Attenuating Painful Stress Response to Skull Pin Insertion in Craniotomies A Randomised Controlled Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/071762
Enrollment
150
Registered
2024-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: G938- Other specified disorders of brain Health Condition 3: G968- Other specified disorders of central nervous system

Interventions

Intervention1: Intrtaveinous and local administration of specific drugs: to compare intravenous and local administration and study as to which drug is more effective in attenuating the painful stress

Sponsors

Armed Forces Medical College, Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for the study are that the patients should be accepted under ASA Grade 1-3, they should be in the age group of 18 - 70 Years and the surgical procedure shall include any craniotomy including Supratentorial Tumors and Cysts in Supine position.

Exclusion criteria

Exclusion criteria: Exclusion criteria includes Patients having a history of known Allergy to study Drugs, Patients having a Glasgow coma scale of 13 or less, Patients with Bradycardia with heart rate less than 50 beats per minute, Patients having a history of Beta Blocker intake, Patients having Uncontrolled Hypertension, Patients taking any Oral Anticoagulant, Patients having impaired Cardiac, Kidney or Liver functions, Patients having any Hematological or Endocrine disorder and Patients having a Second or Third degree heart block.

Design outcomes

Primary

MeasureTime frame
Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure, Blood oxygen saturationTimepoint: At Baseline , After administration of study drugs, Before skull pin fixation, After skull pin fixation at 1, 3, 5, 10, 15 and 20 min respectively

Secondary

MeasureTime frame
Hormonal stress response by measuring serum prolactin, serum cortisol & plasma blood sugar levels before & after skull pin fixation in craniotomiesTimepoint: Before Induction of anesthesia & 30 mins after skull pin fixation

Countries

India

Contacts

Public ContactDr Ajit Bharadwaj

Armed Forces Medical College

rainaajit@gmail.com8171505533

Outcome results

None listed

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